M/MDR - Medical Devices Directive

This document specifies the method for the determination of free, chelated or complexed micronutrients and chelating and/or complexing agents present in compound inorganic micronutrient fertilizers.
This method applies to compound inorganic micronutrient fertilizers when micronutrients are chelated and/or complexed.
The method is based on the determination of the following specific parameters :
-   the water-soluble micronutrient concentration;
-   the fraction of chelated micronutrients in relation;
-   identification of chelating agents EDTA, DTPA, HEEDTA, IDHA, [S,S]–EDDS, [o,o] EDDHA, [o,o] EDDHMA, [o,p] EDDHA, HBED and EDDHSA;
-   the fraction of complexed micronutrients;
-   identification of complexing agents (lignosulfonates, heptagluconic acid (HGA)).
The method is based on
-   ICP (inductive coupled plasma) or FAAS (flame atomic absorption spectrometry) measurement of the concentration of water-soluble micronutrients according to EN 16963 or EN 16965 after extraction according to EN 16962;
-   LC (liquid chromatography) measurement of the chelating agents according to EN 15950, EN 13368-1, EN 13368-2, EN 13368-3, EN 15451, EN 15452;
and/or complexing agents according to EN 16109 and EN 16847;
-   determination of the concentration of chelated micronutrients by CEN/TS 17786-1 and/or CEN/TS 17786-2;
-   determination of the complexed micronutrients by EN 15962.
To avoid duplication of the analytical methods, CEN/TS 17786-2 describes the determination of micronutrients and the identification and determination of chelating agents.

This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
anaesthetic gas delivery system;
anaesthetic breathing system;
anaesthetic gas scavenging system (AGSS);
anaesthetic vapour delivery system;
anaesthetic ventilator;
monitoring equipment;
alarm system;
protection device.
NOTE 1        Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.
An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.
NOTE 2        The applicability of this document is indicated in Table AA.2.
This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories 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 an anaesthetic workstation and its individual components including accessories, as relevant.
Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 3        See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

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 specifies the method for the determination of free, chelated or complexed micronutrients and chelating and/or complexing agents present in compound inorganic micronutrient fertilizers.
This method applies to compound inorganic micronutrient fertilizers when micronutrients are chelated and/or complexed.
The method is based on the determination of the following specific parameters :
-   the water-soluble micronutrient concentration;
-   the fraction of chelated micronutrients in relation;
-   identification of chelating agents EDTA, DTPA, HEEDTA, IDHA, [S,S]–EDDS, [o,o] EDDHA, [o,o] EDDHMA, [o,p] EDDHA, HBED and EDDHSA;
-   the fraction of complexed micronutrients;
-   identification of complexing agents (lignosulfonates, heptagluconic acid (HGA)).
The method is based on
-   ICP (inductive coupled plasma) or FAAS (flame atomic absorption spectrometry) measurement of the concentration of water-soluble micronutrients according to EN 16963 or EN 16965 after extraction according to EN 16962;
-   LC (liquid chromatography) measurement of the chelating agents according to EN 15950, EN 13368-1, EN 13368-2, EN 13368-3, EN 15451, EN 15452;
and/or complexing agents according to EN 16109 and EN 16847;
-   determination of the concentration of chelated micronutrients by CEN/TS 17786-1 and/or CEN/TS 17786-2;
-   determination of the complexed micronutrients by EN 15962.
To avoid duplication of the analytical methods, CEN/TS 17786-2 describes the determination of micronutrients and the identification and determination of chelating agents.

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 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 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 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.

20200402JO- link to MDD,IVD, AIMD and M/023,M/252,M/295 removed. These links are included in the previous published version  EN ISO 15223-1:2016 - JT003045