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This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.

The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO15189.

This document does not specify acceptable levels of risk.

This document does not apply to risks from post-examination clinical decisions made by healthcare providers.

This document does not apply to the management of risks affecting the medical laboratory enterprise that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

NOTE International, national, or regional regulations or requirements may also apply to specific topics covered in this international standard

This document specifies evaluation procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices in order to guarantee the product identity. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts, and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of elastomer and its application.

This document does not specify other requirements for elastomeric parts. These are laid down in the relevant product standards.

This International Standard specifies standardized methods for reporting aberrations of the human eye.

This International Standard specifies a range of Landolt ring optotypes and describes a method for measuring distance visual acuity under photopic conditions for the purposes of certification or licensing.

It is neither intended as a standard for clinical measurements nor for the certification of blindness or partial sight.

In an informative annex other optotypes used in clinical investigations are described.

This international standard specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).

All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.

NOTE Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.

This international standard is applicable to:

a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales

b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.

c) RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM’s intended use statement)

d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.

e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).

This international standard is not applicable to:

a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand.

b) control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;

c) control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;

d) properties reported as nominal scales and ordinal scales, where no magnitude is involved

NOTE 1 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.

NOTE 2 Ordinal scales are often applied to results differentiated into dichotomous groupings (e.g. ‘sick’ vs. ‘healthy’), and may also be applied to results differentiated into non-dichotomous categories where the result categories are rank-ordered but the rank-ordered categories cannot be differentiated in terms of relative degree of difference, e.g. negative, +1, +2, +3 for grading of presence of haemoglobin in urine specimens by visual observation.

This document specifies the requirements for information supplied by the manufacturer for a medical device or accessory, as defined in 3.1. This document includes the generally applicable requirements for identification, marking and documentation of a medical device or accessory. This document does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied.

This document has been prepared to support:

 the essential principles of safety and performance for the information supplied by the manufacturer of a  medical device according to ISO 16142-1:2016 (see Annex C); and

 the essential principles of safety and performance for the information supplied by the manufacturer of an IVD medical device according to ISO 16142-2:2017 (see Annex C);

 IMDRF/GRRP WG/N47:2018 [3] (see Annex D); 

 IMDRF/GRRP WG/N52:— [4] (see Annex D).

NOTE Some authorities with jurisdiction impose additional requirements for the identification, marking and documentation of a medical device or accessory.

The requirements of a medical device-specific product standard take priority over this document.

This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers.

This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.

EN ISO 80601-2-13 was published in 2011. Amendment 1 to EN ISO 80601-2-13:2011 will update this standard with regard to references to IEC 60601-1:2005 (EN 60601-1:2006) and applicable collateral standards. The Amendment 1 also introduces technical modifications to clarify the relationship between this standard and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following aspects, in part due to the publication of amendments that have been published in 2012 and 2013 respectively to IEC 60601-1:2005 and its collateral standards: — addition of a definition on interchangeable anaesthetic vapour delivery system; — marking the mass of mobile me equipment; — movement over a threshold; — rough handling test; — multiple socket-outlets; — specific requirements on anaesthetic gas delivery systems and anaesthetic breathing systems including instructions for use; — vapour concentration during and after oxygen flush; — inspiratory pause. Where appropriate, amendment 1 also includes modifications of specific informative annexes related to the amended requirements as listed above. Finally, minor editorial updates were made.

This document specifies requirements for so-called "cold bubble-through" or "cold pass-over" humidifying equipment, hereafter referred to as a passive humidifier. Figure 1 and Figure 2 illustrate these passive humidifiers.

ISO 27427:2013 specifies requirements for the safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system. ISO 27427:2013 includes gas-powered nebulizers which can be powered by, e.g., compressors, pipeline systems, cylinders, etc., and electrically powered nebulizers [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers.

ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance. ISO 5362:2006 includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of ISO 5362:2006 for the recommended product life. ISO 5362:2006 is not applicable to special-purpose bags, for example bellows and self-expanding bags. Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of ISO 5362:2006.

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; and — intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD). NOTE 1 In the home healthcare environment, the supply mains is often not reliable. NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm 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 IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2. This document does not specify the requirements for: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[4]; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84 [5] [1], the future replacement for ISO 10651‑3[6]; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; — ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80[1]; — sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[7]; — continuous positive airway pressure (CPAP) me equipment; — high-frequency jet ventilators (HFJVs); — high-frequency oscillatory ventilators (HFOVs)[8]; — oxygen therapy constant flow me equipment; — cuirass or "iron-lung" ventilation equipment. This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents. [1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; — intended for transit-operable use; — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm 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 IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2. This document does not specify the requirements for: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[5]; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[6][1], the future replacement for ISO 10651‑3[7]; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; — ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79[1]; — sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[8]; — continuous positive airway pressure (CPAP) me equipment; — high-frequency jet ventilators (HFJVs); — high-frequency oscillatory ventilators (HFOVs)[9]; — oxygen therapy constant flow me equipment; — cuirass or "iron-lung" ventilation equipment. This document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of documents. [1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.