(It includes GI 2.) 1. Scope 1.1 This Standard provides procedures for evaluating polymeric materials and parts made from polymeric materials intended for application in electrical equipment covered by the Canadian Electrical Code, Part II (CEC, P

定价： 546元 / 折扣价： 465 元

1 Scope This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body; c) the selection of appropr

定价： 455元 / 折扣价： 387 元

1 Scope 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 sensitizat

定价： 910元 / 折扣价： 774 元

1 Scope This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion a) with extracts of a device, and/or; b) in

定价： 364元 / 折扣价： 310 元

1 Scope This part of ISO 10993 specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. In addition, it includes pyrogenicity testing. The test methods cited in this p

定价： 410元 / 折扣价： 349 元

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1 Scope This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the preparation of samples of medical devices for testing in biological systems in accordance with one or more other parts of ISO 10993. These inc

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1 Scope This part of ISO 10993 specifies minimum requirements for the use of animals in biological testing. This part of ISO 10993 is also intended (a) to establish guidelines which allow the scientist to respect life in general; (b) to reduce the

定价： 364元 / 折扣价： 310 元

1 Scope 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

定价： 410元 / 折扣价： 349 元

1 Scope This part of ISO 10993 gives guidance to agencies, man ufacturers, research laboratories and others for evaluating the interactions of medical devices with blood. It describes: (a) a classification of medical and dental devices that are int

定价： 728元 / 折扣价： 619 元

1. Scope This Technical Report provides examples of EPE that represent a range of applications from simple to elaborate. They also represent a range of organizations (e.g., manufacturing and service companies; non-governmental organizations; government

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定价： 728元 / 折扣价： 619 元

定价： 819元 / 折扣价： 697 元