IEC 60601

IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, as of 2011 it consists of a general standard, about 10 collateral standards, and about 60 particular standards.

General standard

The general standard IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many countries. Many companies view compliance with IEC 60601-1 as a requirement for most markets. This standard does not assure effectiveness of a medical device. In the US, evidence of effectiveness is required by the FDA and confirmed through either a Premarket Approval (PMA)[1] or similarity to a predicate device via a 510(k) Premarket Notification.[2]

National deviations of this series of standards exist which include country specific requirements;[3][4] see e.g. UL or AAMI for US specifics.[5][6]

The European EN and Canadian CSA versions of the standard are identical to the IEC standard.

Revisions

In 2005, the third edition of IEC 60601-1 was published. It was the result of a comprehensive review of the second edition (dating from 1988). Some key changes are: the outline and the numbering scheme of the clauses and subclauses were changed, risk management was made much more relevant and the concept of essential performance was added. Currently (2012), the applicability of the second and third edition is somewhat overlapping[7][8] depending on the products under consideration and the country/area of application. IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 3rd edition series. IEC 60601-1 merged to medical device directive 93/42/EEC which covers all IEC standard of electromedical & electrical safety so it is clear that EC cover all Previous IEC standard to medical device directive 93/42/EEC

The mandatory date for implementation of the EN European version of the standard is June 1, 2012. The US FDA requires the use of the standard on June 30, 2013, while Health Canada recently extended the required date from June 2012 to April 2013. The North American agencies will only require these standards for new device submissions, while the EU will take the more severe approach of requiring all applicable devices being placed on the market to consider the home healthcare standard.[9]

Collateral and particular standards

Requirements of 60601-1 may be overridden or bypassed by specific language in the standards for a particular product. Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, e.g. Electromagnetic Compatibility (IEC 60601-1-2) or Protection for diagnostic use of X-rays (IEC 60601-1-3). Particular standards (numbered 60601-2-X) define the requirements for specific products or specific measurements built into products, e.g. MR scanners (IEC 60601-2-33) or Electroencephalograms (IEC 60601-2-26).[7][8] Collaterals and Particulars may have their own revisions which are different from the General Standard.

A list of the collateral and particular standards currently in force follows: (last updated 15 September 2016)

  • IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • IEC 60601-1-3 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
  • IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
  • IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-1-9 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
  • IEC 60601-1-10 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
  • IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
  • IEC 60601-1-12 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
  • IEC 60601-2-1 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
  • IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
  • IEC 60601-2-3 Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
  • IEC 60601-2-4 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
  • IEC 60601-2-5 Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
  • IEC 60601-2-6 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
  • IEC 60601-2-8 Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
  • IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
  • IEC 60601-2-11 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
  • IEC 60601-2-16 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
  • IEC 60601-2-17 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
  • IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
  • IEC 60601-2-19 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
  • IEC 60601-2-20 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
  • IEC 60601-2-21 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
  • IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
  • IEC 60601-2-23 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
  • IEC 60601-2-24 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
  • IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
  • IEC 60601-2-26 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
  • IEC 60601-2-27 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
  • IEC 60601-2-28 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
  • IEC 60601-2-29 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
  • IEC 60601-2-31 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
  • IEC 60601-2-33 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
  • IEC 60601-2-34 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
  • IEC 60601-2-36 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
  • IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • IEC 60601-2-39 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
  • IEC 60601-2-40 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
  • IEC 60601-2-41 Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
  • IEC 60601-2-43 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
  • IEC 60601-2-44 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
  • IEC 60601-2-45 Medical electrical equipment - Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices
  • IEC 60601-2-46 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
  • IEC 60601-2-47 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
  • IEC 60601-2-49 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
  • IEC 60601-2-50 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
  • IEC 60601-2-52 Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
  • IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
  • IEC 60601-2-57 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
  • IEC 60601-2-62 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
  • IEC 60601-2-63 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
  • IEC 60601-2-64 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
  • IEC 60601-2-65 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
  • IEC 60601-2-66 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
  • IEC 60601-2-68 Electrical medical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment


For example, IEC 60601-1-9 for Environmentally Conscious Design of Medical Electrical Equipment published July 2007 is a collateral standard to IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Medical Solutions. The Part 9 standard asks manufacturers of medical devices to consider the environmental impacts of their devices throughout the product's entire life cycle and to minimize these where possible. The standard also requires that the manufacturer provide information to the user on how to use the product in the most environmentally sensitive way. The USA, Canada, Japan, Australia and New Zealand have not yet set transition dates for their national versions of this latest edition 60601-1, but the national versions published to date do contain the requirement to also conform with IEC 60601-1-9. However, the European version (EN 60601-1:2006) requires compliance with the new IEC 60601-1-9 collateral standard by September 2009.

According to the recent publication of the US national version of the collateral standard for products intended for home use, ANSI/AAMI HA60601-1-11, the application of the standard does not apply to the nursing home environment. In the United States, nursing facilities are considered to be environments providing professional healthcare. The American version of this collateral standard also places greater emphasis on a requirement that states that “inspection of the usability engineering file reinforce that the usability engineering process is necessary for validation of the instructions for use.” Devices typically mandated to use the new standard include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors, and associated battery chargers prescribed for use at home. Although In Vitro Diagnostic devices such as blood glucose meters are being used by patients at home, the standard does not apply, as these devices remain under the jurisdiction of the more lenient IEC 61010 series.

Critics

The 60601 certification process has been criticized for its complexity, cost, and the business risk it raises. This has been more particularly a concern during the transition to the third edition due to the indefinite adoption schedule of the new revision.[10][11]

See also

References

  1. ^ Health, Center for Devices and Radiological. "Premarket Approval (PMA)". www.fda.gov. Retrieved 2018-02-09.
  2. ^ Health, Center for Devices and Radiological. "Premarket Notification 510(k)". www.fda.gov. Retrieved 2018-02-09.
  3. ^ National Deviations to IEC 60601-1 by MDDI
  4. ^ National Deviations to IEC60601-1 by Eisner Safety Consultants
  5. ^ http://ulstandardsinfonet.ul.com/harm/drafts/medical/s60601-1_1.pdf
  6. ^ http://www.aami.org/news/2010/081010.press.606011.html
  7. ^ a b "Eisner Safety Consultants » FDA Formally Recognize IEC 60601-1, 3rd ed". www.eisnersafety.com. Retrieved 2018-02-09.
  8. ^ a b Regulatory Strategies for the Third Edition of IEC 60601-1 Retrieved 6 September 2010
  9. ^ IEC 60601-1-11:2015 redline version
  10. ^ Op Ed: The 60601-1 Third Edition Is Not Mandatory
  11. ^ How Scary Is IEC 60601-1?

External links

Andhra Pradesh Medtech Zone Limited

Andhra Pradesh MedTech Zone Limited (popularly known as AMTZ) is an enterprise under the Government of Andhra Pradesh to promote medical device manufacturing in India. The goal of this progressive initiative would be to make Andhra Pradesh an internationally recognised manufacturing hub for medical devices, help in national agenda of import substitution, make Andhra Pradesh leader in medical technology exports, generate employment and contribute to volume generated cost reduction of medical devices for patients. A 270 acre-zone is allocated near Vizag steel plant and is dedicated for medical device manufacturing. The objective is to reduce the cost of manufacturing up to 40%, to simplify end-to-end operations for manufacturers, and to reduce import dependency.

Biomedical engineering

Biomedical Engineering (BME) or Medical Engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes (e.g. diagnostic or therapeutic). This field seeks to close the gap between engineering and medicine, combining the design and problem solving skills of engineering with medical biological sciences to advance health care treatment, including diagnosis, monitoring, and therapy.

Also included under the scope of a biomedical engineer is the management of current medical equipment within hospitals while adhering to relevant industry standards. This involves equipment recommendations, procurement, routine testing and preventative maintenance, through to decommissioning and disposal. This role is also known as a Biomedical Equipment Technician (BMET) or clinical engineering.

Biomedical engineering has recently emerged as its own study, as compared to many other engineering fields. Such an evolution is common as a new field transition from being an interdisciplinary specialization among already-established fields, to being considered a field in itself. Much of the work in biomedical engineering consists of research and development, spanning a broad array of subfields (see below). Prominent biomedical engineering applications include the development of biocompatible prostheses, various diagnostic and therapeutic medical devices ranging from clinical equipment to micro-implants, common imaging equipment such as MRIs and EKG/ECGs, regenerative tissue growth, pharmaceutical drugs and therapeutic biologicals.

CEBEC

CEBEC is a private Belgian rating label for the quality assurance of electrical appliances. It stands for "Comité Electrotechnique Belge/Belgisch Elektrotechnisch Comité". Use of this label indicates that a piece of equipment conforms to European safety standards. The label is issued by SGS-CEBEC, now part of the SGS group. CEBEC has its own electrical testing laboratory located in Brussels. It is an approved laboratory for the purpose of certifications granted by SGS.

The laboratory was set up in 2002. In 2004 it was audited by an international team and at the end of 2004 the SGS CEBEC laboratory was approved as a CBTL (CB Testing Laboratory) under the international IECEE-CB scheme. In 2005, it was approved by EEPCA as a laboratory operating in compliance with the CCA, HAR and ENEC agreements.

Comparative Tracking Index

The Comparative Tracking Index or CTI is used to measure the electrical breakdown (tracking) properties of an insulating material. Tracking is an electrical breakdown on the surface of an insulating material wherein an initial exposure to heat chars the material, and the char is more conductive than the original insulator, producing more current flow, more heat, and eventually complete failure.

EEG DIN connector

The EEG DIN connector (also referred to as DIN 42802 or EEG safety DIN connector) is an electrical connector used to connect medical and biomedical recording systems, such as electrodes to electroencephalograph (EEG) as used in neurology. This type of connector is the de facto standard for electromedical instruments as it was adopted by the industry under pressure from regulatory bodies (including the FDA) to impose insulated connectors in clinical settings for safety reasons through the IEC 60601-1 (subclause 56.3(c)) norm.

In 1989, the Deutsches Institut für Normung has issued the 42802 standard which specified a "touch-proof connector for electromedical application".

The EEG DIN connector mainly exist in two types both featuring touch-proof sockets around in-line rigid plugs :

The DIN 42802-1 connector with a 1.5 mm diameter pin

And the E-DIN 42802-2 with a 2 mm diameter pin.

IEC 62304

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

IEC 62366

The international standard IEC 62366 medical devices - Application of usability engineering to medical devices is a standard which specifies usability requirements for the development of medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

ISO 13485

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

The current ISO 13485 edition was published on 1 March 2016.

MOOP

"Moop" or "MOOP" may refer to:

"Matter Out Of Place", a neologism for trash used by Burning Man attendees

A fictional band from the episode "Christian Rock Hard" of South Park

A real band from France

The Medal "For Impeccable Service" in the Soviet Armed Forces

"Means Of Operator Protection". The Standard for medical electrical equipment IEC 60601-1, introduces the concept of MOP, which is further subdivided into MOOP and MOPP.

A term for negative emotions on the cartoon series Bravest Warriors

MOOP (electrical safety)

Means Of Operator Protection, or MOOP, is a concept introduced in the standard for medical electrical equipment IEC 60601-1.

MOPP (electrical safety)

Means of Patient Protection (MOPP) is a concept introduced in the standard for medical electrical equipment IEC 60601-1.

MOP (electrical safety)

Means Of Protection, or MOP, is a concept introduced in the standard for medical electrical equipment IEC 60601-1. The concept is that no one means of protection should be totally necessary to the device's safety, so that the failure of one should not make the device immediately dangerous.MOP is further divided into MOOP and MOPP.

Medisafe International

Medisafe International is a United Kingdom-based company that develops and manufactures products in the field of surgical instrument reprocessing. In 1985, Medisafe introduced the Sonic Irrigation technology to the medical device market. The company has a representation with manufacturing sites in the UK and offices in Florida, Hamburg, Oslo, Buenos Aires and Malta. Medisafe International won the Millennium Price in Great Britain.

Network isolator

Network isolators are installed as part of a wired Ethernet system as galvanic isolators.

Through the applied principle of electromagnetic induction, network data is transmitted across an electrically non-conducting barrier. High frequency AC voltages conveying data are induced across an isolating gap.

The network isolator is a passive device, and functions without any requirement of an external power supply.

Nursing care bed

A nursing care bed (also nursing bed or care bed) is a bed that has been adapted to the particular needs of people who are ill or disabled. Nursing care beds are used in private home care as well as in inpatient care (retirement and nursing homes).

Power entry module

A power entry module (PEM) is an electromechanical component used in electrical appliances, integrating the appliance inlet with other components such as:

a switch, possibly including integrated or remote bowden cable actuation;

a circuit breaker, possibly including overload, overcurrent, or undercurrent protection, as well as remote triggering;

an appliance fuse holder;

a voltage selector;

an electromagnetic interference line filter;

an appliance outlet.Advantages of a power entry module over individual components:

compact dimensions;

unitized, standardized product with pre-assembled individual components;

efficient mounting;

alternative designs with similar dimensions may be substituted without major re-engineering;

protected, pre-wired, tested, and certified power components.Power entry modules are used to save labor in manufacturing electrical and electronic equipment powered by an external source, such as the AC powerline. They are also quite compact, taking up a small amount of space on the equipment’s chassis, or printed circuit board.

Power entry modules frequently allow connections to the equipment circuitry using quick connect tab terminals, also known as blade connectors. An AC inlet connector allows use of a separate, detachable AC line cord that has the type of wall plug favored by the locality. IEC 60320 AC inlet connectors typically used can handle either 120 or 250 volts.

Since most power entry modules connect to the AC powerline, they are subject to safety standards set by Underwriters Laboratories (UL), the Canadian Standards Association (CSA), Verband der Elektrotechnik, Elektronik und Informationstechnik (VDE), and many other safety standards agencies such as the BSI Group (BSI). Power entry module manufacturers take on the responsibility of producing power entry module products in such a way that they meet the standards of one or more of these safety standard agencies, so that equipment manufacturers using them need not take responsibility for the internal details of safety certification. Power entry module manufacturers also pay independent testing labs to test their products against the safety standards, so that the products can carry the safety agency’s approval mark.

Typical AC power entry modules often have dielectric strengths of 2000 volts or more, and can handle currents of up to 10 to 20 amperes at 250 volts maximum. Exceeding the ratings can cause unsafe operation and must be avoided.

Medical devices can and do take advantage of power entry modules. Power entry modules are available with electromagnetic interference filters with very low leakage current ratings, even those suitable for direct patient contact in accordance with UL 544 and IEC 60601-1. Shock-safe fuseholders have also been integrated into power entry modules. These devices require a tool to remove the fuse for replacement.

DC (Direct current) power entry modules have been less common, but are finding popularity with equipment manufacturers, especially those that supply equipment in both AC- and DC-powered versions. The DC-powered versions of such equipment are frequently used in telephone exchange applications.

Power entry modules are also available rated as water resistant at IP65, with seal protection at the panel opening, around the fuse holders when provided, and between the inlet housing and connector pins.

Specific absorption rate

Specific absorption rate (SAR) is a measure of the rate at which energy is absorbed by the human body when exposed to a radio frequency (RF) electromagnetic field. It can also refer to absorption of other forms of energy by tissue, including ultrasound. It is defined as the power absorbed per mass of tissue and has units of watts per kilogram (W/kg).SAR is usually averaged either over the whole body, or over a small sample volume (typically 1 g or 10 g of tissue). The value cited is then the maximum level measured in the body part studied over the stated volume or mass.

Surgical lighting

A surgical light – also referred to as an operating light or surgical lighthead – is a medical device intended to assist medical personnel during a surgical procedure by illuminating a local area or cavity of the patient. A combination of several surgical lights is often referred to as a “surgical light system”.

Veinoplus

Veinoplus is a class IIa medical device with CE marking. It is indicated for the treatment of vascular diseases. This is a neuromuscular stimulator developed by an American scientist, Jozef Cywinski.

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