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This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.

This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408-7.

This document specifies a test method and the minimum requirements for bactericidal 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.
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This document applies to products that are used in the veterinary area for disinfecting non-porous surfaces without mechanical action i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
NOTE This method corresponds to a Phase 2 Step 2 test.
This method excludes the evaluation of the activity of products against yeasts, fungal spores, mycobacteria and bacterial spores.

ISO 16840-2:2018 specifies apparatus, test methods and disclosure requirements for wheelchair seat cushions intended to maintain tissue integrity and prevent tissue trauma. Test conditions simulate a symmetric anatomy and posture and do not represent cushion performance for specific individual users. Loads are intended to represent those seen under the pelvis of a 50th percentile wheelchair user and are not intended to assess the weight capacity of the cushion or to characterize the cushion under bariatric loads. It is possible that not all test methods apply to existing and future cushion technologies. It does not include test methods or requirements for determining the fire resistance of cushions.


ISO 16840-2:2018 can also be applicable to tissue integrity management devices used as other support systems, as well as to cushions used in situations other than a wheelchair.
 

1.1 This document specifies requirements and guidelines for systems and equipment used toevacuate plume generated by medical devices.
1.2 This document applies to all types of plume evacuation systems (PESs), including
a) portable;
b) mobile;
c) stationary, including dedicated central pipelines;
d) PESs integrated into other equipment;
e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic).
1.3 This document applies to all healthcare facilities where PESs are used, including, but not limited to
a) surgical facilities;
b) medical offices;
c) cosmetic treatment facilities;
d) medical teaching facilities;
e) dental clinics;
f) veterinary facilities.
1.4 This document provides guidance on the following aspects of PESs:
a) importance;
b) purchasing;
c) design;
d) manufacture;
e) documentation;
f) function;
g) performance;
h) installation;
i) commissioning;
j) testing;

k) training;
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
1.5 This document does not apply to the following:
a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination; and
e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

This document provides guidance to manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial hydrogel, composite and rigid gas-permeable (RGP) contact lenses intended for multipatient use.
This document does not apply to:
— labelling of contact lenses;
— the inactivation of prions and viruses since there are no standardised methods available for contact lenses.
This document can be used as guidance for the development of a hygienic management procedure for multipatient use.
NOTE ISO 14729 does not cover multipatient use.

This European Standard specifies a test method and the minimum requirements for virucidal 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.
This European Standard applies to products that are used in the veterinary area on non-porous surfaces without mechanical action i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
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 2 test.
NOTE 3 Using this European Standard, it is possible to determine the virucidal activity of the undiluted product.
NOTE 4 This standard uses Porcine Parvovirus because Bovine Enterovirus Type 1 (ECBO) virus used in the suspension test EN 14675 cannot be used for surface testing because of its loss of titre during drying. Porcine
Parvovirus has comparable resistance to ECBO virus.

ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient.
ISO 80601-2-55:2018 specifies requirements for
- anaesthetic gas monitoring,
- carbon dioxide monitoring, and
- oxygen monitoring.
NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.
ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents.
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+Amd 1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+Amd 1:2012, 4.2.

This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both.
NOTE 1 This type of connection is primarily used for small cylinders (5 l or below).
NOTE 2 In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa =
105 N/m2).
This document specifies:
— basic dimensions;
— requirements for alternative designs of the yoke-type valve connections;
— dimensions and positions for the holes and pins for the outlet connections.
It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.

This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

This document specifies the characteristics of, and corresponding test methods for, forgeable and coldformed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
NOTE The mechanical properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

This International Standard provides guidelines in the survey of user needs of persons with impaired seeing and hearing functions for assistive products and services. It was developed to meet the increasing demand for developing information on user needs of assistive products. Various methods
and techniques have been developed for survey of user needs in market, opinion, and social survey.
This document includes the methods relevant to survey user needs of assistive products.
In order to carry out a survey on persons with impaired sensory functions, communication shall be accessible to participants. The instructions and questions should be easily understandable by the participants and participants should be encouraged to express their replies. Accessibility requirements necessary for surveying persons with impaired sensory functions are addressed in this document. This document is mainly concerned with the assistive products devoted for persons with impaired sensory functions, but does not provide guidelines for including other types of disabilities like physical, mental or cognitive impairments.
This document includes a survey on assistive products and services when used by persons with reduced sensory functions.
Questions on the extent of the impairment and the context of use of assistive products are important, but questions concerning the personal situation and medical causes of persons with impaired sensory functions should not be part of the survey.
Impaired sensory functions in this document are mainly related to seeing, hearing impairments.

ISO 10524-1:2018 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.
ISO 10524-1:2018 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.

This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ ASTM F139.

This document specifies requirements and test methods of walking sticks with three or more legs being used as assistive products for walking, manipulated by one arm, without accessories, unless specified
in the particular test procedure. This document also gives requirements related to safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling.
The requirements and tests are based on every-day use of walking sticks with three or more legs as assistive products for walking for a maximum user mass as specified by the manufacturer. This document is for walking sticks with three or more legs specified for a user mass of no less than 35 kg.
This document is not applicable to walking sticks with three or more legs with underarm or forearm support or with moving parts such as a universal joint.