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This part of ISO 1452 specifies the general aspects of unplasticized poly(vinyl chloride) (PVC-U) solid-wall piping systems intended for water supply and for buried and above-ground drainage and sewerage under pressure. In conjunction with ISO 1452-2, ISO 1452-3, ISO 1452-4 and ISO 1452-5, it is applicable to PVC-U pipes, fittings, valves and ancillary equipment, their joints and to joints with components of other plastics and nonplastics materials intended to be used for the following: a) water mains and services buried in the ground; b) conveyance of water above ground for both outside and inside buildings; c) buried and above-ground drainage and sewerage under pressure. It is applicable to piping systems intended for the supply of water under pressure up to and including 25 °C (cold water), intended for human consumption and for general purposes as well as for waste water under pressure. This part of ISO 1452 is also applicable to components for the conveyance of water and waste water up to and including 45 °C. For temperatures between 25 °C and 45 °C, Figure A.1 of ISO 1452-2:2009 applies. NOTE The producer and the end-user can come to agreement on the possibilities of use for temperatures above 45 °C on a case-by-case basis.

Document Number: NL ISO 14160 : 2014

Sector: Health Care Technology

Status: C

Production Year: 2014

Price: 35000.0000

This International Standard 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 International Standard 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 International Standard is not applicable to material of human origin. This International Standard does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see Note 2). This International Standard 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 International Standard 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 International Standard 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 International Standard does not cover the level of residual sterilizing agent within medical devices (see Note 6). This International Standard does not describe a quality management system for the control of all stages of manufacture (see Note 7). NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1, is important. 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 International Standard 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. NL ISO 14160:2014 ISO 14160:2011(E) 2 © ISO 2011 – All rights reserved 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 defined 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.

Information supplied by the manufacturer of medical devices

Document Number: NL EN 1041 : 2014

Sector: Health Care Technology

Status: C

Production Year: 2014

Price: 35000.0000

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.