The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed …
ISO/TC 210 in Stockholm and IEC/SC 62A in Sao Polo. 13 EN ISO 14971:2012 EU地域では2013年1月から強制となった。 ISO 14971:2007との違いはANNEX Z（ ZA,ZB,ZC) 要求事項の差はISO 14971：2007とは無い MDDを 2019/08/09 2016/12/30 DS/ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements × Close Hardcopy Hardcopy Sprog € 59.60 Pris: € 59.60 Add to ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.
Status: Gyldig Norsk tittel: Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — … 2016/11/02 ISO 15223-1 - 2016-11 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements. Inform now! We use cookies to make our website more user-friendly and 2008/03/13 ISO 15223-1 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices . This first edition of ISO 15223-1, together with the proposed part 2 of ISO 15223, cancels and replaces ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation. ISO/TC 210 in Stockholm and IEC/SC 62A in Sao Polo. 13 EN ISO 14971:2012 EU地域では2013年1月から強制となった。 ISO 14971:2007との違いはANNEX Z（ ZA,ZB,ZC) 要求事項の差はISO 14971：2007とは無い MDDを
BS EN ISO 15223-1:2016 Title Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements Status Current, Work in hand Publication Date 31 December 2016 , , DIN EN ISO 15223-1 - DRAFT August 2015 Draft Document - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2015 ラベル上にある二次元バーコードの規格 二次元バーコードの場合、バーコード検証機は、シンボルの構造や各モジュールの反射率を分析します。ラベル上にある二次元コードは、ISO 15415 規格の 8 つの異なるパラメータに従って評価されます。 BS EN ISO 15223-1 2016 Edition, December 31, 2016 Complete Document Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements Includes all Sphere of EN ISO 15223-1:2016: Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere Publications in the Official Journal: (EU)2020 ISO 15223-1:2016(E) 3.2 description normative text which defines the purpose, application and use of the symbol [SOURCE: IEC 80416-1:2008, 3.2] 3.3 label written, printed or graphic information provided upon the medical device itself ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document. ISO
ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.
BS EN ISO 15223-1:2016 Title Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements Status Current, Work in hand Publication Date 31 December 2016 , , DIN EN ISO 15223-1 - DRAFT August 2015 Draft Document - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2015 ラベル上にある二次元バーコードの規格 二次元バーコードの場合、バーコード検証機は、シンボルの構造や各モジュールの反射率を分析します。ラベル上にある二次元コードは、ISO 15415 規格の 8 つの異なるパラメータに従って評価されます。 BS EN ISO 15223-1 2016 Edition, December 31, 2016 Complete Document Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements Includes all Sphere of EN ISO 15223-1:2016: Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere Publications in the Official Journal: (EU)2020 ISO 15223-1:2016(E) 3.2 description normative text which defines the purpose, application and use of the symbol [SOURCE: IEC 80416-1:2008, 3.2] 3.3 label written, printed or graphic information provided upon the medical device itself ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document. ISO