This Technical Reports describes quality designations and indications for algae and directly derived products from algae production required for or by pharma producers and industry. It does not apply to Food and Feed sectors.
Note: This TRs does not provide instructions on existing handling of technical requirements in existing legislations.

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  • Technical report
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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.

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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.

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This European Standard specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

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This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041.
This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.

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Deals with the safety of hand-held motor-operated or magnetically driven electric tools, the rated voltage of the tools being not more than 250 V for single-phase a.c. or d.c. tools, and 440 V for three-phase a.c. tools. This standard deals with the common hazards presented by hand-held tools which are encountered by all persons in the normal use and reasonably foreseeable misuse of the tools.

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This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.

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Establishes definitions, requirements, methods of testing and rated values for phase-to-earth capacitive and screen-to-earth intrusive inductive coupling devices to be used in medium voltage DLC systems.

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This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It 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. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).

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This part of ISO 22442 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 nonviable.
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 part of ISO 22442 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 part of ISO 22442 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 part of ISO 22442 does not specify a quality management system for the control of all stages of
production of medical devices.
This part of ISO 22442 does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this part of ISO 22442 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 part of ISO 22442, see Annex A.

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This part of ISO 22442 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 1 Selective sourcing is considered to be especially important for transmissible spongiform
encephalopathy (TSE) risk management.
The manufacturers should refer to ISO 22442‑3 for information on the validation of the elimination
and/or inactivation of viruses and TSE agents.
This part of ISO 22442 does not cover the utilization of human tissues in medical devices.
This part of ISO 22442 does not specify a quality management system for the control of all stages of
production of medical devices.
It is not a requirement of this part of ISO 22442 to have a full quality management system during
manufacture, but it does specify requirements for some of the elements of a quality management
system. Attention is drawn to the standards for quality management systems (see ISO 13485) that
control all stages of production or reprocessing of medical devices. The quality management system
elements that are required by this part of ISO 22442 can form a part of a quality management system
conforming to ISO 13485.
NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due
consideration to the requirements and recommendations contained in all three parts of the standard.

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ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.
ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

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TC - Figures B.1 and B.2 to be replaced

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This European Standard specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

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TC - Figures B.1 and B.2 to be replaced

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This European Standard specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

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ISO 15225:2010 provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users.
ISO 15225:2010 includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein.
The requirements contained in ISO 15225:2010 are applicable to the development and maintenance of an international nomenclature for medical device identification.
ISO 15225:2010 does not include the nomenclature itself, which is provided as a data file.

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This part of ISO 22442 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 part of ISO 22442 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.

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This part of ISO 22442 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.

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This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It 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. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
NOTE   When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

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This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It 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. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
NOTE   When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

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This European Standard specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard are not intended to apply to symbols specified in other standards. However, every effort should be made to prevent the specifying of different symbols with the same meaning. This standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 375, EN 376, EN 591, EN 592 and EN 1041.

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ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

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This European Standard specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard are not intended to apply to symbols specified in other standards. However, every effort should be made to prevent the specifying of different symbols with the same meaning. This standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 375, EN 376, EN 591, EN 592 and EN 1041.

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This European Standard specifies requirements and guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers, and End Users. NOTE: This European Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases utilizing the nomenclature system described herein.

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This European Standard specifies requirements and guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers, and End Users. NOTE: This European Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases utilizing the nomenclature system described herein.

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This standard specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.

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This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices.
NOTE   This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in EN 1041.

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This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices.
NOTE   This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in EN 1041.

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This part of prEN 12442 specifies requirements for the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing materials of animal origin. It is not applicable to bacteria, moulds and yeasts.

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This Part of prEN 12442 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. Note 1: Requirements for the riks analysis of the use of materials of animal origin in medical devices are described in prEN 12442-1.

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This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis).

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This Part of prEN 12442 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. Note 1: Requirements for the riks analysis of the use of materials of animal origin in medical devices are described in prEN 12442-1.

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This part of prEN 12442 specifies requirements for the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing materials of animal origin. It is not applicable to bacteria, moulds and yeasts.

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This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis).

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65.62 is synchronized with the special DOW of EN ISO 14971:2000 = 2004-03-31.

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This part of ISO 10993 specifies methodologies for the evaluation of the systematic toxicity potential of medical devices with release constituents into the body. In addition, it includes pyrogenicity testing.  The test methods cited in this part of ISO 10993 are from International Standards, national standards, directives and regulations. This part of ISO 10993 is concerned with either the actual product or its leachables. It is intended that tests for extracts or leachables be conducted by choosing appropriate extraction vehicles to yield a maximum  extraction of leachable materials, in order to conduct biological testing.

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This part of ISO 10993 specifies tests for the following biological aspects:   - genotoxicity,  - carcinogenicity; and  - reproductive and developmental toxicity.   These are relevant in the biological evaluation of some categories of medical and dental materials and devices (see note). Guidance on selection of tests is provided in ISO 10993-1. Where the need for the evaluation of the potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified, they should be evaluated in accordance with this part of ISO 10993.  Most tests included in this part of the International Standard refer to the OECD guidelines for testing of chemicals. Reference to these tests is made by the term 'OECD guideline(s)' followed by the appropriate test number(s).  At the time of testing, these tests are to be performed according to current OECD guidelines.  Note: The term 'devices' corresponds to the definition given in ISO 10993-1 and covers materials, as well as dental materials and devices. The definition is in accordance with the CEN standard document.

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This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices.  Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.

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Migrated from Progress Sheet (TC Comment) (2000-07-10): UAP of 6 months (TC Res C 1/1998) (CC/980930)

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This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices.  Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.

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This part of ISO 10993 provides a guide for agencies, manufacturers, research laboratories and others for evaluating the interactions of medical and dental materials and devices with blood.   It describes:  a)  a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1;   b)  the fundamental principles governing the evaluation of the interaction of devices with blood;  c) the rationale for structured selection of tests, together with the principles and scientific basis of these tests.  Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood.

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This part of ISO 10993 describes test methods:  a) to evaluate the potential of devices and their constituent materials to produce irritation; and  b) to evaluate the potential of devices and their constituent materials to produce sensitization.  These test methods are recommended for most categories of device and mode of body contact given in ISO 10993-1. Of the tests listed, those appropriate to the end use of the device are to be selected. Guidance is also given for the preparation of materials specifically in relation to the above tests.  Note 1: Guidance on the conduct of supplementary tests which may be required specifically for use in the oral, rectal, penile and vaginal areas is given in Annex D.

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