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SS EN 1441 Ed. 1 (1998)被替代

Medical Devices - Risk Analysis

出版：Standardiserings-Kommissionen I Sverige

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基本信息
標(biāo)準(zhǔn)編號(hào)： SS EN 1441 Ed. 1 (1998)
發(fā)布時(shí)間：1998/4/17 0:00:00
標(biāo)準(zhǔn)類(lèi)別：Standard
出版單位：Standardiserings-Kommissionen I Sverige
標(biāo)準(zhǔn)頁(yè)數(shù)：25
標(biāo)準(zhǔn)簡(jiǎn)介

Defines a method for investigation by the manufacturer of the safety of a medical device, including in vitro diagnostic devices or accessories, by identification of hazards and estimation of the risks associated with the device. Particularly helpful in areas where relevant standards are unavailable or unused. Does not define levels of acceptability, or give detailed guidance on management of risks. Nor does it cover decision-making processes regarding assessing the indications and contra-indications for using a particular device.

替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)

SS EN ISO 14971 Ed. 3 (2009)

SS EN ISO 14971 Ed. 2 (2007)

等同采用的國(guó)際標(biāo)準(zhǔn)

ONORM EN 1441:1998 - Identical

UNI EN 1441:1998 - Identical

I.S. EN 1441:1998 - Identical

NS EN 1441:1998 - Identical

UNE EN 1441:1998 - Identical

SN EN 1441:1998 - Identical

NEN EN 1441:1997 - Identical

BS EN 1441:1998 - Identical

DIN EN 1441 (1998-01) - Identical