1、August 2016 English price group 27No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 03.120.10; 11.040.01!%Y.9“2541122
2、www.din.deDIN EN ISO 13485Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485:2016);English version EN ISO 13485:2016,English translation of DIN EN ISO 13485:2016-08Medizinprodukte Qualittsmanagementsysteme Anforderungen fr regulatorische Zwecke (ISO 13485:2016
3、);Englische Fassung EN ISO 13485:2016,Englische bersetzung von DIN EN ISO 13485:2016-08Dispositifs mdicaux Systmes de management de la qualit Exigences des fins rglementaires (ISO 13485:2016);Version anglaise EN ISO 13485:2016,Traduction anglaise de DIN EN ISO 13485:2016-08SupersedesDIN EN ISO 13485
4、:2012-11See start of applicationwww.beuth.deDocument comprises 69 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.08.16 DIN EN ISO 13485:2016-08 2 A comma is used as the decimal marker. Start of application The start of applica
5、tion of this standard is 2016-08-01. For DIN EN ISO 13485:2012-11 there is a transition period ending on 2019-03-31. National foreword This document (EN ISO 13485:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” (Sec
6、retariat: ANSI, USA) in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Med
7、ical), Working Committee NA 063-01-13 AA Qualittsmanagement und entsprechende allgemeine Aspekte fr Medizinprodukte. The translation of the verb forms in this document complies with DIN 820-2:2012-12, Annex H (ISO/IEC Directives Part 2:2011, modified). The following provisions apply: “shall” (in Ger
8、man “muss”) indicates a requirement; “should” (in German “sollte”) indicates a recommendation; “may” (in German “darf”) indicates a permission; “can” (in German “kann”) indicates a possibility or a capability. In addition, when drafting DIN EN ISO 13485, the following translations were taken as a ba
9、sis: “establish and maintain” have been translated into the German “erstellen und aufrechterhalten”; “design and development” has been translated into the German “Entwicklung”; “nonconform” and “nonconformity” have been translated into the German “nichtkonform” and “Nichtkonformitt”. This standard i
10、ntentionally uses the term “nonconformity” (German “Nichtkonformitt”) and not the term “error”. The terms are not identical in meaning. “Error” is a legal term that plays a role in warranties for defects and product liability. Nonconformity differs from this term in that it refers to manufacturers o
11、wn specifications not adhering to those agreed upon with the customer or those expected by the market. Clause 3 of this document contains definitions that are partly specified in national regulatory provisions. In Germany, the following definitions are specified in legally binding form in the Medizi
12、nproduktegesetz MPG (Act on Medical Devices): “authorized representative” (in German “Bevollmchtigter”) (see MPG 3 No. 16) “manufacturer” (in German “Hersteller”) (see MPG 3 No. 15) “medical device” (in German “Medizinprodukt”) (see MPG 3 No. 1) “importer” (in German “Einfhrer”) (see MPG 3 No. 26) D
13、IN EN ISO 13485:2016-08 3 The definition of product (in German “Produkt”) from ISO 9000:2005 was included in the standard after a final vote without consultation with the responsible international committee. According to the responsible national body, this definition is not in line with the usage of
14、 the term “product” and “medical device” (in German “Medizinprodukt”) in other parts of this standard. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 9000 DIN EN ISO 9000 ISO 9001 DIN EN ISO 9001 ISO 10012 DIN EN ISO 10012 ISO 11607-1
15、DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 11644 DIN EN ISO 11644 ISO 14698 DIN EN ISO 14698 ISO 14791 DIN EN ISO 14791 ISO 19011 DIN EN ISO 19011 IEC 62366-1 DIN EN 62366-1 (VDE 0750-241-1) Amendments This standard differs from DIN EN ISO 13485:2012-11 as follows: a) the standard has bee
16、n based on ISO 9001:2008; b) the scope has been expanded to include language stating that this standard can be used by 1) organizations that are involved in one or more stages of the life-cycle of a medical device, 2) suppliers or external parties; c) definitions have been added; d) requirements on
17、documentation have been revised and expanded; e) requirements on the use of a risk-based approach have been integrated; f) requirements on the validation of the use of computer software have been added; g) requirements on infrastructure as well as the work environment and contamination control have
18、been added; h) requirements on product realization have been expanded; i) requirements on measurement, analysis and improvement have been added; j) Annex A on the changes as compared with the previous edition of ISO 13485:2003 has been revised; k) Annex B has been revised to show the correspondence
19、between ISO 13485:2016 and ISO 9001:2015; DIN EN ISO 13485:2016-08 4 l) Annexes ZA, ZB and ZC have been updated, which show the relationship between the essential requirements of EU Directive 90/385/EEC on active implantable medical devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diag
20、nostic medical services, and which include excerpts from this standard; m) the standard has been editorially revised. Previous editions DIN EN 46001: 1993-12, 1996-09 DIN EN 46002: 1993-12, 1996-08 DIN EN ISO 13485: 2001-02, 2003-11, 2010-01, 2012-11 National Annex NA (informative) Bibliography DIN
21、EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment DIN EN ISO 11607-1, Packaging for terminally sterilized medical
22、 devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes DIN EN ISO 11644 (all parts), Cleanrooms and associated contr
23、olled environments DIN EN ISO 14698-1, Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles DIN EN ISO 14698-2, Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data D
24、IN EN ISO 14791, Medical devices Application of risk management to medical devices DIN EN ISO 19011, Guidelines for auditing management systems DIN EN 62366-1 (VDE 0750-241), Medical devices Part 1: Application of usability engineering to medical devices EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE
25、NORM EN ISO 13485 March 2016 ICS 03.120.10; 11.040.01 Supersedes EN ISO 13485:2012 English version Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)Dispositifs mdicaux - Systmes de management de la qualit - Exigences des fins rglementaires (ISO 1348
26、5:2016) Medizinprodukte - Qualittsmanagementsysteme - Anforderungen fr regulatorische Zwecke (ISO 13485:2016) This European Standard was approved by CEN on 30 January 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving
27、 this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member. This European Standard exists in
28、three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members ar
29、e the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
30、Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Mem
31、bers and for CENELEC Members. Ref. No. EN ISO 13485:2016 EEuropean foreword .4Introduction 71 Scope 102 Normative references . 103 Terms and definitions 104 Quality management system . 154.1 General requirements 154.2 Documentation requirements. 164.2.1 General. 164.2.2 Quality manual . 164.2.3 Medi
32、cal device file . 164.2.4 Control of documents . 174.2.5 Control of records 175 Management responsibility . 185.1 Management commitment . 185.2 Customer focus 185.3 Quality policy . 185.4 Planning . 185.4.1 Quality objectives . 185.4.2 Quality management system planning 185.5 Responsibility, authori
33、ty and communication 195.5.1 Responsibility and authority 195.5.2 Management representative . 195.5.3 Internal communication . 195.6 Management review 195.6.1 General. 195.6.2 Review input .195.6.3 Review output .206 Resource management 206.1 Provision of resources . 206.2 Human resources . 206.3 In
34、frastructure 216.4 Work environment and contamination control .216.4.1 Work environment 216.4.2 Contamination control .217 Product realization .217.1 Planning of product realization . 217.2 Customer-related processes . 227.2.1 Determination of requirements related to product 227.2.2 Review of requir
35、ements related to product 227.2.3 Communication 237.3 Design and development . 237.3.1 General. 237.3.2 Design and development planning 237.3.3 Design and development inputs 237.3.4 Design and development outputs 247.3.5 Design and development review .247.3.6 Design and development verification .247
36、.3.7 Design and development validation .247.3.8 Design and development transfer 257.3.9 Control of design and development changes 257.3.10 Design and development files 25Contents PageForeword 6DIN EN ISO 13485:2016-08 EN ISO 13485:2016 (E) 2 7.4 Purchasing . 267.4.1 Purchasing process .267.4.2 Purch
37、asing information 267.4.3 Verification of purchased product .267.5 Production and service provision 277.5.1 Control of production and service provision 277.5.2 Cleanliness of product 277.5.3 Installation activities .277.5.4 Servicing activities 287.5.5 Particular requirements for sterile medical dev
38、ices287.5.6 Validation of processes for production and service provision 287.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems .287.5.8 Identification 297.5.9 Traceability 297.5.10 Customer property 297.5.11 Preservation of product 297.6 Control of
39、 monitoring and measuring equipment 308 Measurement, analysis and improvement .318.1 General 318.2 Monitoring and measurement 318.2.1 Feedback 318.2.2 Complaint handling 318.2.3 Reporting to regulatory authorities .318.2.4 Internal audit .318.2.5 Monitoring and measurement of processes 318.2.6 Monit
40、oring and measurement of product .318.3 Control of nonconforming product 338.3.1 General. 338.3.2 Actions in response to nonconforming product detected before delivery .338.3.3 Actions in response to nonconforming product detected after delivery 338.3.4 Rework 338.4 Analysis of data 338.5 Improvemen
41、t . 348.5.1 General. 348.5.2 Corrective action .348.5.3 Preventive action 34Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016 36Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015 .39Bibliography .65Annex ZA (informative) Relationship bet
42、ween this European Standard and the Essential Requirements of EU Directive 90/385/EEC (as amended) 45 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC (as amended) 50 Annex ZC (informative) Relationship between this European
43、Standard and the Essential Requirements of EU Directive 98/79/EC 57 DIN EN ISO 13485:2016-08 EN ISO 13485:2016 (E) 3 European foreword This document (EN ISO 13485:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in c
44、ollaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement
45、, at the latest by September 2016, and conflicting national standards shall be withdrawn at the latest by March 2019. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying
46、 any or all such patent rights. This document supersedes EN ISO 13485:2012. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see
47、informative Annex ZA, ZB and ZC, which are integral parts of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, D
48、enmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this
