SIST EN 556-1:2002/AC:2006
(Amendment)Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE'. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated " STERILE".
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als 'STERIL' gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1: Exigences relatives aux dispositifs médicaux stérilisés au stade terminal
Sterilizacija medicinskih pripomočkov – Zahteve za medicinske pripomočke, ki morajo biti označeni s "STERILNO" – 1. del: Zahteve za končno sterilizirane medicinske pripomočke
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Frequently Asked Questions
SIST EN 556-1:2002/AC:2006 is a corrigendum published by the Slovenian Institute for Standardization (SIST). Its full title is "Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices". This standard covers: This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE'. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated " STERILE".
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE'. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated " STERILE".
SIST EN 556-1:2002/AC:2006 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 556-1:2002/AC:2006 has the following relationships with other standards: It is inter standard links to SIST EN 556-1:2024, SIST EN 556-1:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 556-1:2002/AC:2006 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devicesULOL]LUDQHStérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1: Exigences relatives aux dispositifs médicaux stérilisés au stade terminalSterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als 'STERIL' gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurdenTa slovenski standard je istoveten z:EN 556-1:2001/AC:2006SIST EN 556-1:2002/AC:2006en,de11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:SLOVENSKI
STANDARDSIST EN 556-1:2002/AC:200601-december-2006
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 556-1:2001/ACSeptember 2006Septembre 2006September 2006ICS 11.080.01English versionVersion FrançaiseDeutsche FassungSterilization of medical devices - Requirements for medical devices to bedesignated 'STERILE' - Part 1: Requirements for terminally sterilizedmedical devicesStérilisation des dispositifs médicaux -Exigences relatives aux dispositifsmédicaux en vue d'obtenir l'étiquetageSTERILE - Partie 1: Exigences relativesaux dispositifs médicaux stérilisés au stadeterminalSterilisation von Medizinprodukten -Anforderungen an Medizinprodukte, die als'STERIL' gekennzeichnet werden - Teil 1:Anforderungen an Medizinprodukte, die inder Endpackung sterilisiert wurdenThis corrigendum becomes effective on 20 September 2006 for incorporation in the three officiallanguage versions of the EN.Ce corrigendum prendra effet le 20 septembre 2006 pour incorporation dans le
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The article discusses the requirements outlined in the SIST EN 556-1:2002/AC:2006 European Standard for medical devices to be considered 'STERILE'. Part 1 of the standard focuses on terminally-sterilized medical devices, while Part 2 addresses aseptically processed medical devices. The standard sets out specific guidelines that must be met in order for a medical device to be designated as sterile.
기사 제목: SIST EN 556-1:2002/AC:2006 - 의료기기 살균 - 'STERILE'로 지정될 의료기기에 대한 요구 사항 - 제1부: 최종 살균된 의료기기에 대한 요구 사항 기사 내용: 이 유럽 표준은 'STERILE'로 지정되기 위한 최종 살균된 의료기기의 요구 사항을 명시한다. 이 유럽 표준의 제2부에서는 'STERILE'로 지정되기 위한 무균적으로 처리된 의료기기에 대한 요구 사항을 명시한다.
記事のタイトル：SIST EN 556-1:2002/AC:2006 - 医療機器の滅菌 - 「STERILE」と指定されるための医療機器の要件 - 第1部：最終的に滅菌された医療機器の要件 記事の内容：この欧州標準は、「STERILE」と指定されるための最終的に滅菌された医療機器の要件を規定しています。この欧州標準の第2部では、「STERILE」と指定されるための無菌処理された医療機器の要件を規定しています。
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