2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL
LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This particular standard does not apply to
– headlights;
– endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18;
– luminaires used in dentistry, which are covered by ISO 9680;
– luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4;
– luminaires dedicated to therapeutic purposes;
– special purpose lights with different conditions of use such as light sources intended solely
for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps
for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
– lights connected to surgical instruments, such as luminous retractors;
– luminaires for emergency lighting, which are covered by IEC 60598-2-22.
NOTE See also 4.2 of the general standard.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general
lighting equipment.

This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This document applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.
NOTE 1   The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2   This method corresponds to a phase 2 step 1 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

This document provides general principles for the systematic evaluation of the potential and observed
degradation of medical devices through the design and performance of in vitro degradation studies.
Information obtained from these studies can be used in the biological evaluation described in the
ISO 10993 series.
This document is applicable to both materials designed to degrade in the body as well as materials that
are not intended to degrade.
This document is not applicable to:
a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the
production of this type of degradation product are described in specific product standards, where
available;
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from
the scope of this document, such degradation products can evoke a biological response and can undergo
biological evaluation as described in other parts of ISO 10993.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly

This document specifies general requirements for medical suction equipment that are common to all parts of the 10079 series.
The ISO 10079 series does not apply to the following:
a)   end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b)   syringes;
c)   dental suction equipment;
d)   anaesthetic gas scavenging systems;
e)   laboratory suction;
f)   autotransfusion systems;
g)   mucus extractors including neonatal mucus extractors;
h)   suction equipment where the collection container is downstream of the vacuum pump;
i)   ventouse (obstetric) equipment;
j)   suction equipment marked for endoscopic use only
k)   plume evacuation systems.

This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1   Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2   Environmental aspects are addressed in Annex A.

EN-ISO 80601-2-90 applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: - intended for use with patients who can breathe spontaneously; and - intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities.

This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that
enters normally sterile parts of the human body or a medical device that comes into contact with
mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements
to assist manufacturers of medical devices in providing detailed processing instructions that consist of
the following activities, where applicable:
a) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— textile devices used in patient draping systems or surgical clothing;
— medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a
medical device

This document specifies symbols used to express information supplied for a medical device. This
document is applicable to symbols used in a broad spectrum of medical devices, that are available
globally and need to meet different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging or in the accompanying
information. The requirements of this document are not intended to apply to symbols specified in other
standards

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of
washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical
devices.
NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the
context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable
medical devices.

This document specifies requirements for the characterization of a liquid chemical sterilizing agent
and for the development, validation, process control and monitoring of sterilization by liquid chemical
sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
This document covers the control of risks arising from contamination with bacteria and fungi by
application of a liquid chemical sterilization process. Risks associated with other microorganisms can
be assessed using other methods (see NOTE 1).
This document is not applicable to material of human origin.
This document does not describe methods for the validation of the inactivation of viruses and
transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).
This document does not describe methods for validation of the inactivation or elimination of protozoa
and parasites.
The requirements for validation and routine control described in this document are only applicable
to the defined sterilization process of a medical device, which is performed after the manufacturing
process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).
This document does not specify tests to establish the effects of any chosen sterilization process upon
the fitness for use of the medical device (see NOTE 5).
This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).
Guidance for the characterization of a liquid chemical sterilizing agent and for the development,
validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of
single-use medical devices comprising, in whole or in part, materials of animal origin is provided in
informative Annex A.
NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as
described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during
processing of cell-based health-care products.
NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices
might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy
(BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate
inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal
materials are described in ISO 22442-2.
NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE
agents is described in ISO 22442-3.
NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include
exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the
manufacturing process, a medical device is exposed to a specified sterilization process.
NOTE 5 Such testing is a crucial part of the design and development of a medical device.
NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.
NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of
manufacture including the sterilization process.

This document specifies requirements and gives guidance on the procedures in the preparation of
samples and the selection of reference materials for medical device testing primarily in biological test
systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
— test sample selection;
— selection of representative portions from a medical device;
— test sample preparation;
— experimental controls;
— selection of, and requirements for, reference materials;
— preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device
components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the
exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization.
Information given in C.1 to C.4 can also be relevant.

This particular standard applies to basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS), which is a unique application of NIRS in that it employs multiple wavelengths of light energy and time-resolved (frequency or time domain) and/or spatially resolved methods to derive a quantitative measure of tissue oxygen saturation of haemoglobin within the field of the NIRS sensor. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME EQUIPMENT for those environments of use.
Not included within the scope of this particular standard are:
a) Invasive tissue or vascular oximeters
b) Device measuring dissolved oxygen
c) Functional NIRS device covered by IEC 80601-2-71, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes
d) Pulse oximeter covered by ISO 80601-2-61, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes; however, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use.
NOTE: a manufacturer may claim monitoring of tissue other than cerebral, which is not covered
by this standard.

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

2021-02.09 -JO - positive assessment for MDD (EN IEC 60601-2-83:2020 - PR= 64477) and the comments of the HAS consultant for MDR was resolved by the TC for EN IEC 60601-2-83:2020/prA11 - PR= 72969
This A11 introduces a revised Annex ZA & Annex ZZ  to EN IEC 60601-2-83:2020 in view of offering it for citation in OJEU under MDD (93/42/EEC) and MDR (2017/745)

This document specifies requirements for electrically heated shell boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft.
NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities.
This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.
EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function.
EXAMPLE 2 An oxygen concentrator used with a flowmeter stand.
EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2].
EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.
This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator.
NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.
This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
NOTE 3 See also 4.2 of the general standard.

This particular standard is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as me equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.
This particular standard is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.
This particular standard is only applicable to active devices (e.g. Pneumatically or electrically powered) and is not applicable to non-active devices (e.g. Reservoir cannulas).

This particular standard is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
This particular standard excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This particular standard is applicable to me equipment or an ME system intended for those patients who are not dependent on mechanical ventilation such as patients with central sleep apnoea.
This particular standard is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.

The proposed Technical Report is to provide a common understanding of post-market surveillance, or
PMS facilitating international cooperation in this area. The Technical Report is intended for use by
manufacturers of medical devices. With PMS, the manufacturers can collect, evaluate, and analyze experience gained with their devices after placing on the market. The resulting information can be used for, among others, improvement of the devices.
The proposed Technical Report aims to describe a comprehensive data collection process and activities that allow characterization of the behavior of the devices as used in practice, and identify necessary and/or possible actions. PMS information may include material that requires reporting to Regulatory Authorities. The proposed Technical Report will not provide information for such reporting, nor for achieving compliance with any other (PMS) requirement by Regulatory Authorities.
Market surveillance by national authorities, as well as actions legally required to be performed by manufacturers as part of PMS or vigilance are outside the scope of the proposed Technical Report. The document is not intended to replace or change national or regional legislation on PMS.

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to
—     protect the rights, safety and well-being of human subjects,
—     ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
—     define the responsibilities of the sponsor and principal investigator, and
—     assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
NOTE 1  Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.
NOTE 2  For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.

This document is one of a series of standards describing the characteristics for identification cards as defined in the definitions clause and the use of such cards for international interchange.
This document specifies requirements for a high coercivity magnetic stripe (including any protective overlay) on an identification card and encoding technique. It takes into consideration both human and machine aspects and states minimum requirements.
Coercivity influences many of the quantities specified in this document but is not itself specified. The main characteristic of the high coercivity magnetic stripe is its improved resistance to erasure. This is achieved with minimal probability of damage to other magnetic stripes by contact while retaining read compatibility with magnetic stripes as defined in ISO/IEC 7811-2.
This document provides for a card capacity of approximately 10 times that of a card conforming to ISO/IEC 7811-6. The number of tracks has been increased to 6, each track being approximately half the width of tracks conforming to ISO/IEC 7811-6, located so that readers designed to read these high density tracks will also be able to read cards conforming to ISO/IEC 7811-2 and ISO/IEC 7811-6. Data is encoded in 8 bit bytes using the MFM encoding technique. Data framing is used to limit error propagation and error correction techniques further improve reliability of reading.
It is the purpose of the ISO/IEC 7811 series of standards to provide criteria to which cards shall perform. No consideration is given within these standards to the amount of use, if any, experienced by the card prior to test. Failure to conform to specified criteria is negotiated between the involved parties.
ISO/IEC 10373-2 specifies the test procedures used to check cards against the parameters specified in this document.
NOTE Numeric values in the SI and/or Imperial measurement system in this document may have been rounded off and are consistent with, but not exactly equal to each other. Using either system is correct but intermixing or reconverting values can result in errors. The original design was made using the Imperial measurement system.

EN-ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products.

EN-IEC 60601-2-83 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR. The scope of this document includes all light sources except laser. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

IEC 60601-2-83:2019 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR. The scope of this document includes all light sources except laser.

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance

This Standard specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).

20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for  the assessment report E&Y Report

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].

20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance

1.1    Inclusions
1.1.1    This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.
NOTE       Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.
1.1.2    This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
1.2    Exclusions
1.2.1    This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE       See ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3.
1.2.2    This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556‑1.
1.2.3    This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE       It is not a requirement of this document to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009.
1.2.4    This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.
NOTE 1    Safety requirements for sterilizers are specified in IEC 61010‑2‑040.
NOTE 2    Attention is also drawn to the existence in some countries of regulations stipulating safety requirements.
1.2.5    This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products.
NOTE 1    Attention is drawn to EN 14180.
NOTE 2    Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products.
1.2.6    This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.
NOTE       For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).

20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for  the assessment report E&Y Report

IEC 60601-2-46:2010 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1.

This document provides guidance on auditing management systems, including the principles of auditing,
managing an audit programme and conducting management system audits, as well as guidance on
the evaluation of competence of individuals involved in the audit process. These activities include the
individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of
management systems or manage an audit programme.
The application of this document to other types of audits is possible, provided that special consideration
is given to the specific competence needed.

This document specifies:
—          the general principles governing the biological evaluation of medical devices within a risk management process;
—          the general categorization of medical devices based on the nature and duration of their contact with the body;
—          the evaluation of existing relevant data from all sources;
—          the identification of gaps in the available data set on the basis of a risk analysis;
—          the identification of additional data sets necessary to analyse the biological safety of the medical device;
—          the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:
—          the patient's body during intended use;
—          the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).
This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
—          risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
—          breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear

This document specifies requirements and provides guidance on the enumeration and microbial
characterization of the population of viable microorganisms on or in a health care product, component,
raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
This document does not apply to the enumeration or identification of viral, prion or protozoan
contaminants. This includes the removal and detection of the causative agents of spongiform
encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022.
This document does not apply to the microbiological monitoring of the environment in which health
care products are manufactured.

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
detail specified requirements for designating a medical device as sterile;
specify a quality management system for the control of all stages of production of medical devices;
specify requirements for occupational safety associated with the design and operation of irradiation facilities;
specify requirements for the sterilization of used or reprocessed devices.

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
detail specified requirements for designating a medical device as sterile;
specify a quality management system for the control of all stages of production of medical devices;
specify requirements for occupational safety associated with the design and operation of irradiation facilities;
specify requirements for the sterilization of used or reprocessed devices.

EN ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
NOTE 1   The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2   This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.

2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant