M/023 - Medical devices

This document specifies the general requirements for instruments to be used in association with nonactive
surgical implants. These requirements apply to instruments when they are manufactured and
when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term “instrument” refers to an instrument for use in
association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it
does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design
attributes, materials, design evaluation, manufacture, sterilization, packaging, and information
supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and
transradicular implants and ophthalmic implants.

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 applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It
specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations
associated with such devices, to estimate and evaluate the resulting risks, to control these risks,
and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the
residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and
expected medical benefit as compared to available alternatives. This document is intended to provide
requirements and guidance on risk management related to the hazards typical of medical devices
manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a
multiplicity of factors, cannot be set down in such an international standard except for some particular
derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow
derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production
of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture.
However, attention is drawn to international standards for quality management systems (see ISO 13485) that
control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.

This document specifies requirements for controls on the sourcing, collection, and handling (which
includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing
materials of animal origin other than in vitro diagnostic medical devices. It applies where required by
the risk management process as described in ISO 22442-1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk
management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine
species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production
of medical devices.

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 document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers,
but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products intended to be used for treatment in aqueous systems against Legionella pneumophila that form a homogeneous, physically stable preparation when diluted with buffered ferrous hard water or hard water. Whenever Legionella pneumophila poses a risk to human health, this method is suitable for water used in cooling towers and water for general purposes, like spas, pools, showers and other uses. The method is not suitable for electro-chemical disinfection.
The European Standard applies to products used to treat water in order to kill Legionella pneumophila.
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 .
NOTE 3   This method does not take into account the fact that Legionella pneumophila is often found in cells of amoebae and/or biofilms and that thereby a product’s activity against the bacteria may be reduced.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendation".

This European Standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport, monitoring, treatment and care of patients. It contains requirements for the patient’s compartment in terms of the working environment, ergonomic design and the safety of the crew and patients.This European Standard does not cover the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.
This European Standard is applicable to road ambulances capable of transporting at least one person on a stretcher and excludes the transportation of hospital beds.
This standard also specifies requirements for ambulances intended to carry transport incubator systems.
The European Standard covers the specific requirements of each type of road ambulance which are
designated according to the patient condition e.g. patient transport road ambulance types A1, A2, B and C.
This European Standard gives general requirements for medical devices carried in road ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.

This document specifies dimensions and requirements for both open and closed suction catheters made
of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

This document specifies requirements for the evaluation of stent systems (vascular stents and delivery
systems) and requirements with respect to nomenclature, design attributes and information supplied
by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro
test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies
general requirements for the performance of non-active surgical implants.
NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to
the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not
always available. As further scientific and clinical data become available, appropriate revision of this document
will be necessary.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular
scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of
the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent
systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this
document, comprehensive requirements and testing are not described for these uses. Similarly, specific
stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and
testing are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion,
including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated
endovascular prosthesis), are within the scope of this document, but test methods are not described for
the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical
evaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within the
scope of this document. Stents covered with materials that significantly modify the permeability of the
uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The
stent design or intended use might dictate the need to address functional requirements identified in
both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses,
stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document provides
requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with
vascular stents.
This document is not applicable to procedures and devices used prior to the introduction of the vascular
stent, such as balloon angioplasty devices.
Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow
diverters are within the scope of this document, but comprehensive requirements and testing are not
described for these devices.
Although drug-eluting stents are within the scope of this document, this document is not comprehensive
with respect to the drug-eluting properties of these devices.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1.
Although absorbable stents and stents with absorbable coatings are within the scope of this document,
this document is not comprehensive with respect to the absorbable properties of these devices.
NOTE 3 Absorbable implants are within the scope of ISO/TS 17137.
Although coated stents and coated stent systems are within the scope of this document, this document
is not comprehensive with respect to coatings.
NOTE 4 Some coating properties are within the scope of ISO 17327-1.
This document does not address the requirements for, and the evaluation of, viable tissues and nonviable
biologic materials used in the construction of vascular stents.

This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible
blades, with internal battery-operated power sources, used for illuminating the larynx during
intubation. It also specifies critical dimensions for those handles and laryngoscope blades with
interchangeable hook‐on fittings.
It is not applicable to the following:
— flexible laryngoscopes;
— laryngoscopes designed for surgery;
— laryngoscopes powered from mains electricity supply;
— laryngoscopes connected by light‐transmitting cables to external light sources;
— video laryngoscopes designed to work with an external, integral or attached video system.

This document is intended especially to ensure the gas-specific assembly, mechanical resistance, flow,
leakage and pressure drop of terminal units and to prevent their interchange between different gases
and services and applies to terminal units:
a) intended for use in medical gas pipeline systems in accordance with ISO 7396-1;
b) used as pressure outlets on pressure regulators in accordance with ISO 10524-1;
c) used as pressure outlets on pressure regulators integrated with cylinder valves (VIPR) in
accordance with ISO 10524-3.
This document applies to terminal units for use with the following gases for administration to patients
or for medical uses (A):
— oxygen (A);
— nitrous oxide (A);
— medical air (A);
— carbon dioxide (A);
— oxygen/nitrous oxide mixture (A);
— helium/oxygen mixtures (A);
— oxygen 93 (A);
— gases and gas mixtures classified as medical device (A);
— gases delivered to medical devices or intended for medical purposes (A);
— gases and gas mixtures for medicinal use not specified above (A).
This document applies to terminal units for use with the following gases (B):
— air for driving surgical tools (B);
— nitrogen for driving surgical tools (B).
This document applies to terminal units for use with vacuum systems (C).
NOTE The requirements of this document can be used as guidelines for terminal units for other gases. These
other gases will be considered for inclusion in this document when they come into general use.
This document specifies requirements for terminal units for supply and disposal of nitrogen and air for
driving surgical tools.
This document specifies requirements for probes intended to be connected to the gas-specific
connection point.
This document does not specify the dimensions of probes or of the gas-specific connection points.
NOTE Regional or national standards specifying dimensions of probes and gas-specific connection points
are given in the Bibliography.
Other connection systems in national use may be acceptable under this document. Dimensioning for
such connections will be specified by their respective national standards.
This document does not specify the requirements for terminal units for anaesthetic gas scavenging
systems (AGSS), which are specified in ISO 9170-2.

This document specifies requirements and provides the test method for medical gloves for single use in order to determine freedom from holes.

DOW = DAV + 36 months

This part of EN 13718 specifies the requirements for performance and equipping for air ambulances, including requirements for interfaces to medical devices used for the transport and treatment of sick or injured persons. This part of EN 13718 is applicable to air ambulances capable of transporting at least one person on a stretcher.
NOTE   Requirements are specified for categories of air ambulances based on the different intended use. These are the helicopter emergency medical service (HEMS) the helicopter intensive care medical service (HICAMS) and the fixed wing air ambulance (FWAA).

This European Standard specifies general requirements for medical devices carried in air ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.

EN-ISO 80601-2-12 applies to the basic safety and essential performance of a ventilator in combinationwith its accessories, hereafter referred to as ME equipment:- intended for use in an environment that provides specialized care for patients whoseconditions can be life-threatening and who can require comprehensive care and constantmonitoring in a professional healthcare facility;considered as an emergency medical services environment ventilator.- intended to be operated by a healthcare professional operator; and- intended for those patients who need differing levels of support from artificial ventilationincluding for ventilator-dependent patients.A critical care ventilator is not considered to utilize a physiologic closed-loop-control systemunless it uses a physiological patient variable to adjust the ventilation therapy settings.This document is also applicable to those accessories intended by their manufacturer to beconnected to a ventilator breathing system, or to a ventilator, where the characteristics of thoseaccessories can affect the basic safety or essential performance of the ventilator.

This European Standard specifies general requirements for medical devices carried in air ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.

This part of EN 13718 specifies the requirements for performance and equipping for air ambulances, including requirements for interfaces to medical devices used for the transport and treatment of sick or injured persons. This part of EN 13718 is applicable to air ambulances capable of transporting at least one person on a stretcher.
NOTE   Requirements are specified for categories of air ambulances based on the different intended use. These are the helicopter emergency medical service (HEMS) the helicopter intensive care medical service (HICAMS) and the fixed wing air ambulance (FWAA).

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
intended to be operated by a healthcare professional operator; and
intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
NOTE 4 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 IEC 60601-1:2005, 7.2.13 and 8.4.1.
NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2];
ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4];
ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72:2015[5];
ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7][1];
obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[9];
continuous positive airway pressure (CPAP) ME equipment;
high-frequency jet ventilators (HFJVs) and hi

This document specifies requirements for thedevelopment and validation of processes for packaging medical devices that areterminally sterilized. These processes include forming, sealing and assembly ofpreformed sterile barrier systems, sterile barrier systems and packagingsystems. It is applicable to industry, to health care facilities, and towherever medical devices are packaged and sterilized. It does not cover allrequirements 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.

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

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.

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 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 assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance

2019-10-07: CEN/BT 169/2019: remove link to MDD + MDR & publish without delay
2019-10-09 - JO- BT decision - BT N 11739 - remove link to MDD
20180720 - TAN - Consultant assessment rejected
CEN/BT C082/2011:  DOW = DAV + 36 months

This Standard applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment. This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.

This International Standard specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment centre. It specifies the efficiency of the amalgam separators in terms of the level of retention of amalgam based on a laboratory test and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the amalgam separator, for marking, and for instructions for use, operation and maintenance. All tests described in this International Standard are type tests.

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.
This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.
NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.
Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.

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).

2019-10-07: CEN/BT 169/2019: remove link to MDD + MDR & publish without delay
2019-10-09 - JO- BT decision - BT N 11739 - remove link to MDD
20180720 - TAN - Consultant assessment rejected
CEN/BT C082/2011:  DOW = DAV + 36 months

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

2019-10-07: CEN/BT 169/2019: remove link to MDD + MDR & publish without delay
2019-10-09 - JO- BT decision - BT N 11739 - remove link to MDD
CEN/BT C082/2011:  DOW = DAV + 36 months

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged. This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units. Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use. This document is not applicable to plastics containers with an integrated filter.

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged.
This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.
Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use.
This document is not applicable to plastics containers with an integrated filter.

SIST EN-ISO 80601-2-61 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER. These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED. The intended use of PULSE OXIMETER EQUIPMENT includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS in the HOME HEALTHCARE ENVIRONMENT and the EMERGENCY MEDICAL SERVICES ENVIRONMENT. This document is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory research applications nor to oximeters that require a blood sample from the PATIENT. 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 201.11 and in 7.2.13 and 8.4.1 of the general standard. This document can also be applied to ME EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability. This document is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use. This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the PATIENT ENVIRONMENT. This document is applicable to PULSE OXIMETER EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply PULSE OXIMETER EQUIPMENT for those environments of use. This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

This document specifies the design, construction, type testing, and marking requirements for pressure
regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures
in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving
surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to pressure regulators:
a) intended to be connected to cylinders by the operator;
b) with integral flow-metering devices intended to be connected to cylinders by the operator;
c) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators,
resuscitators).
A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable
or pre-set.
pressure regulators are intended to be fitted to refillable cylinders with a working pressure up
to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the
medical gas delivered.

CEN/BT C082/2011:  DOW = DAV + 36 months
20180110 - TAN - Cannot be allocated for publication because of rejected consultant's assessment.
2019-01-14 - JO: BT N 11332 (BT C160/2018) for CEN TC 215 to remove link from the MDD (93/42/EEC) and Mandate M/023

CEN/BT C082/2011:  DOW = DAV + 36 months
TAN - Consultant assessment Rejected at FDIS stage.
2019-01-14 - JO: BT N 11332 (BT C160/2018) for CEN TC 215 to remove link from the MDD (93/42/EEC) and Mandate M/023

This document specifies design, type testing, and marking requirements for cylinder valves with
integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with
integrated pressure regulators (VIPRs)] intended for the administration of medical gases in
the treatment, management, diagnostic evaluation and care of patients or for gases used for driving
surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to VIPRs mounted on refillable cylinders with a working pressure up to
30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used
in homecare applications.
VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or
pre-set flow outlet(s).

This document specifies design, construction, type testing, and marking requirements for manifold
pressure regulators (as defined in 3.7) and line pressure regulators (as defined in 3.5) intended
for use in medical gas pipeline systems.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to manifold pressure regulators and line pressure regulators supplied
as individual units or to the relevant components incorporated within an assembly.
Manifold pressure regulators are intended to be connected to a manifold system which has a
nominal inlet pressure, P1 of up to 30 000 kPa (300 bar).
Line pressure regulators are intended to be connected downstream of the manifold pressure
regulator with a supply pressure up to 3 000 kPa (30 bar).
This document does not apply to pressure regulators for use with vacuum pipeline systems.
NOTE Requirements for pressure regulators for use with vacuum pipeline systems are covered in
ISO 10079-3.

This document specifies the particular requirements, including performance criteria for washerdisinfectors
(WD) that are intended to be used for cleaning and chemical disinfection of thermolabile
endoscopes.
This document also specifies the performance requirements for the cleaning and disinfection of the
washer-disinfector and its components and accessories which can be required to achieve the necessary
performance criteria.
The methods, instrumentation and instructions required for type testing, works testing, validation
(installation, operational and performance qualification on first installation), routine control and
monitoring, and requalification of WD periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of
activities covered by this document.
NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other
thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this
method of disinfection.
WD complying with the requirements of this document are not intended for cleaning and disinfection
of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or
sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).
The specified performance requirements of this document do not ensure the inactivation or removal of
the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of
cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or
other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.
NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement
on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
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 201.11 and in 7.2.13 and 8.4.1 of the general standard.
NOTE 1 See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance.
ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use.
ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.
ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use.
ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications.
VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).

CEN/BT C082/2011:  DOW = DAV + 36 months
20180110 - TAN - Cannot be allocated for publication because of rejected consultant's assessment.
2019-01-14 - JO: BT N 11332 (BT C160/2018) for CEN TC 215 to remove link from the MDD (93/42/EEC) and Mandate M/023

ISO 10524-2:2018 specifies design, construction, type testing, and marking requirements for manifold pressure regulators (as defined in 3.7) and line pressure regulators (as defined in 3.5) intended for use in medical gas pipeline systems.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
ISO 10524-2:2018 applies to manifold pressure regulators and line pressure regulators supplied as individual units or to the relevant components incorporated within an assembly.
Manifold pressure regulators are intended to be connected to a manifold system which has a nominal inlet pressure, P1 of up to 30 000 kPa (300 bar).
Line pressure regulators are intended to be connected downstream of the manifold pressure regulator with a supply pressure up to 3 000 kPa (30 bar).
ISO 10524-2:2018 does not apply to pressure regulators for use with vacuum pipeline systems.
NOTE Requirements for pressure regulators for use with vacuum pipeline systems are covered in ISO 10079‑3.