SIST EN ISO 13485:2016/AC:2018

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2016) - Popravek AC

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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SLOVENSKI STANDARD
SIST EN ISO 13485:2016/AC:2018
01-maj-2018
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SIST EN ISO 13485:2016/AC:2017
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Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO 13485:2016)
Ta slovenski standard je istoveten z: EN ISO 13485:2016/AC:2018
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
SIST EN ISO 13485:2016/AC:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13485:2016/AC:2018
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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SIST EN ISO 13485:2016/AC:2018
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10


EUROPEAN STANDARD EN ISO 13485:2016/AC

NORME EUROPÉENNE
March 2018


EUROPÄISCHE NORM
ICS 03.100.70; 11.040.01
English version

Medical devices - Quality management systems - Requirements for regulatory
purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de Medizinprodukte -
management de la qualité - Exigences à des Qualitätsmanagementsysteme -
fins réglementaires (ISO 13485:2016) Anforderungen für regulatorische Zwecke
(ISO 13485:2016)
This corrigendum becomes effective on 28 March 2018 for incorporation in the official English version of
the EN.






CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2018 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members
and for CENELEC Members.
Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde
entier aux membres nationaux du CEN et aux membres du CENELEC.
Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den
nationalen Mitgliedern von CEN und den Mitgliedern von CENELEC vorbehalten.
Ref. No. EN ISO 13485:2016:EN ISO 13485:2016/AC:2018 E

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SIST EN ISO 13485:2016/AC:2018
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN ISO 13485:2016/AC:2018 (E)
1 Modification to the European foreword
Replace the current fourth paragraph
"This document supersedes EN ISO 13485:2012."
with the following:
"This document supersedes EN ISO 13485:2012 and CEN ISO/TR 14969:2005."
2 Modification to the heading of Annex ZA
Replace the current heading of Annex ZA with:
"Relationship between this European Standard and the Conformity Assessment Requirements of EU
Directive 90/385/EEC (as amended)".
3 Modifications to ZA.0
st
Replace the 1 paragraph with the following:
"This European Standard has been prepared under a mandate given to CEN/CENELEC by the European
Union and the European Free Trade Association to provide a means by which a manufacturer may
demonstrate conformity, and by which the Notified Body may assess the manufacturer’s conformity,
with the requirements of Directive 90/385/EEC (as amended) on active implantable medical devices."
rd
Delete the 3 paragraph starting with "EN ISO 13485:2016 provides requirements…".
st
In NOTE 1, 1 sentence, replace the reference to the Directive with "Directive 90/385/EEC" to read:
"NOTE 1 Where a reference from a clause of this European Standard to the risk management process is made,
the risk management process needs to be in compliance with Directive 90/385/EEC, as amended by
2007/47/EC."
Delete the last sentence in NOTE 2 to read:
"NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 4, 5, 8, 9 and 10 of the Directive."
4 Modifications to ZA.1
nd
In Table ZA.1, 12th row relating to 3.2, 3rd paragraph (b), replace in the 2 column "5.1.1" with "5.1" to
read:
"
3.2, 3rd paragraph (b) 4.2.2, 5.1 Covered.
"
nd
In Table ZA.1, 15th row relating to 3.2 3rd paragraph (b) 3rd indent, replace in the 2 column "8.5.1"
with "8.2.2" to read:
"
3.2 3rd paragraph (b) 3rd 1, 4.1, 4.2, 7.4, Covered.
indent 8.2.2
"
2

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SIST EN ISO 13485:2016/AC:2018
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN ISO 13485:2016/AC:2018 (E)
nd
In Table ZA.1, 23th row relating to 3.2, 3rd paragraph (e), delete in the 2 column "7.5.1" to read:
"
3.2, 3rd paragraph (e) 4.2, 7.1, 7.4.3, Covered provided that the documented frequency at
7.5.9.1, 7.6, 8.2.6 which tests are carried out is detailed in the quality
management system documentation.
"
nd
In Table ZA.2, 13th row relating to 3.2, 3rd paragraph (b), 3rd indent, replace in the 2 column "8.5.1"
with "8.2.2" to read:
"
3.2, 3rd paragraph (b), 3rd 1, 4.1, 4.2, 7.4, Covered.
indent 8.2.2
"
nd
In Table ZA.2, 15th row relating to 3.2, 3rd paragraph (c), 2nd indent, replace in the 2 column "7.5.3"
with "7.5.8, 7.5.9" to read:
"
3.2, 3rd paragraph (c), 2nd 4.2, 7.5.8, 7.5.9 Covered.
indent
"
Last paragraph, replace the existing text of WARNING 1 and WARNING 2 with the following:
"WARNING: The preceding text and tables are specifically intended for organizations that need to
comply with the European Directive 90/385/EEC in order to affix CE marking on their products and for
other parties involved in that process. Other Directives might also be applicable and require a CE
marking."
5 Modification to the heading of Annex ZB
Replace the current heading of Annex ZB with:
"Relationship between this European Standard and the Conformity Assessment Requirements of EU
Directive 93/42/EEC (as amended)"
6 Modifications to ZB.0
st
Replace the 1 paragraph with the following:
"This European Standard has been prepared under a mandate given to CEN/CENELEC by the European
Union and the European Free Trade Association to provide a means by which a manufacturer may
demonstrate conformity, and by which the Notified Body may assess the manufacturer's conformity,
with the requirements of Directive 93/42/EEC (as amended) on medical devices."
rd
Delete the 3 paragraph starting with "EN ISO 13485:2016 provides requirements…".
Delete the last sentence in NOTE 2 to read:
"NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive."
3

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SIST EN ISO 13485:2016/AC:2018
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN ISO 13485:2016/AC:2018 (E)
7 Modifications to ZB.1
nd
In Table ZB.1, 14th row relating to 3.2, 3rd paragraph (b), 2nd indent, replace in the 2 column "8.2.2"
with "8.2.4" to read:
"
3.2, 3rd paragraph (b), 4.1, 5.6, 7.1, 8.2.4, Covered provided that the methods and acceptance
2nd indent 8.3, 8.4, 8.5.2, 8.5.3 criteria chosen by the manufacturer ensure that the
requirements of the Directive are fulfilled.
"
nd
In Table ZB.1, 15th row relating to 3.2, 3rd paragraph (b), 3rd indent, replace in the 2 column "8.5.1"
with "8.2.2" to read:
"
3.2, 3rd paragraph (b), 1, 4.1, 4.2, 7.4, 8.2.2 Covered.
3rd indent
"
In Table ZB.1, replace the 27th row relating to 3.2, 3rd paragraph (d) with:
"
rd 4.2, 7.1, 7.5, 7.6, 8.1, Covered.
3.2, 3 paragraph (d)
8.2.5, 8.2.6
"
nd
In Table ZB.1, 32th row relating to 3.2, 3rd paragraph (e), delete in the 2 column "7.5.1" and replace
"8.2.4" with "8.2.6" to read:
"
3.2, 3rd paragraph (e) 4.2, 7.1, 7.4.3, Covered provided that the documented frequency at
7.5.9.1, 7.6, 8.2.6 which tests are carried out is detailed in the quality
management system documentation.
"
nd
In Table ZB.2, 15th row relating to 3.2 3rd paragraph (b) 2nd indent, replace in the 2 column "8.2.2"
with "8.2.4" to read:
"
3.2 3rd paragraph (b) 4.1, 5.6, 7.1, 8.2.4, Covered provided that the methods and acceptance
2nd indent 8.3, 8.4, 8.5.2, 8.5.3 criteria chosen by the manufacturer ensure that the
requirements of the Directive are fulfilled.
"
nd
In Table ZB.2, 16th row relating to 3.2 3rd paragraph (b) 3rd ind
...