Issue date: 5/1/2014

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Modification date: 17/2/2016
(TM-SOP-05-05/F1) Page1of 2

Date of Applicatio
cessation n
of
presump
First Reference of tion of
Reference and title of the harmonized standard
publication superseded conformi
(and reference document)
OJ standard ty of
supersed
ed
standard
Note 1

EN 556-1:2001 EN 556:1994 + Date Sterilization

Sterilization of medical devices - Requirements for A1:1998 expired validation
31/07/2002
medical devices to be designated "STERILE" - Part 1: (30/04/20
CEN 02)
Requirements for terminally sterilized medical devices

EN 556-1:2001/AC:2006 15/11/2006

EN 556-2:2015 Sterilization of medical devices — This is the Sterilization

Requirements for medical devices to be designated validation
CEN first EN 556-2:2003 30.6.2016
‘STERILE’ — Part 2: Requirements for aseptically
processed medical devices publication

EN ISO 10993-1:2009 EN ISO 10993- Date Biocomptab

Biological evaluation of medical devices - Part 1: 1:2009 expired ity testing
02/12/2009
Evaluation and testing within a risk management (21/03/20
CEN 10)
process (ISO 10993-1:2009)

EN ISO 10993-1:2009/AC:2010 18/01/2011

Biocomptab
EN ISO 10993-3:2014 EN ISO 10993- ity testing
3:2009 Date
Biological evaluation of medical devices - Part 3: Tests ofgenotoxic
CEN 10.7.2015 expired
for genotoxicity, carcinogenicity and reproductive ity,
13.5.2016
toxicity (ISO 10993-3:2014) carcinogeni
city

EN ISO 10993-4:2009 Biocomptab

EN ISO 10993- Date
ity testing
Biological evaluation of medical devices - Part 4: 4:2002 expired
CEN 02/12/2009 of
Selection of tests for interactions with blood (ISO (21/03/20
heamocom
10993-4:2002, including Amd 1:2006) 10)
ptability

EN ISO 10993-5:2009 EN ISO 10993- Date Biocomptab

5:1999 expired ity testing
CEN Biological evaluation of medical devices - Part 5: Tests 02/12/2009
(31/12/20 of
for in vitro cytotoxicity (ISO 10993-5:2009) 09) cytotoxicity

CEN EN ISO 10993-6:2009 02/12/2009 EN ISO 10993- Date Biocomptab

6:2007 expired ity testing
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Biological evaluation of medical devices - Part 6: Tests (21/03/20 of muscle

for local effects after implantation (ISO 10993-6:2007) 10) implantatio
n

Biocomptab
EN ISO 10993-7:2008
ity testing
Biological evaluation of medical devices - Part 7: 19/02/2009 E.O
Ethylene oxide sterilization residuals (ISO 10993-
CEN residual
7:2008)
testing

EN ISO 10993-7:2008/AC:2009 07/07/2010

EN ISO 10993-11:2009 EN ISO 10993- Date Biocomptab

11:2006 expired ity testing
CEN Biological evaluation of medical devices - Part 11: Tests 02/12/2009
(21/03/20 of systemic
for systemic toxicity (ISO 10993-11:2006) 10) toxicity

EN ISO 10993-12:2012 (new) This is the EN ISO 10993- Biocomptab

Biological evaluation of medical devices - Part 12: first 12:2009 31/01/20 ity testing
CEN publication sample
Sample preparation and reference materials (ISO 13
10993-12:2012) 24/1/2013 extraction

CEN EN ISO 10993-13:2010 (new) 18/01/2011 EN ISO 31/12/20

Biological evaluation of medical devices - Part 13: 10993- 10
Identification and quantification of degradation 13:2009
products from polymeric medical devices (ISO
10993-13:2010) Note 2.1

EN ISO 11135-1:2014 Sterilization

Date validation
Sterilization of health care products - Ethylene oxide - EN 550:1994
expired
CEN Part 1: Requirements for development, validation and 09/08/2007
(31/05/20
routine control of a sterilization process for medical 10)
devices (ISO 11135-1:2014)

EN ISO 11138-2:2009 EN ISO 11138- Date Sterilization

Sterilization of health care products - Biological 2:2006 expired validation
CEN 02/12/2009
indicators - Part 2: Biological indicators for ethylene (21/03/20
oxide sterilization processes (ISO 11138-2:2006) 10)

EN ISO 11607-1:2009 EN ISO 11607- Date Packing

Packaging for terminally sterilized medical devices - 1:2006 expired validation
CEN 02/12/2009
Part 1: Requirements for materials, sterile barrier (21/03/20
systems and packaging systems (ISO 11607-1:2006) 10)

EN ISO 11607-2:2006 Packing

Packaging for terminally sterilized medical devices - validation
CEN 07/09/2006
Part 2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2006)
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EN 1174- Bioberden
2:1996 testing
EN ISO 11737-1:2006 EN 1174-
Date
1:1996
Sterilization of medical devices - Microbiological expired
07/09/2006 EN 1174-
methods - Part 1: Determination of a population of (31/10/20
CEN 3:1996
microorganisms on products (ISO 11737-1:2006) 06)

EN ISO 11737-1:2006/AC:2009 02/12/2009

EN ISO 11737-2:2009 Bioberden

Sterilization of medical devices - Microbiological testing
CEN methods - Part 2: Tests of sterility performed in the 07/07/2010
definition, validation and maintenance of a sterilization
process (ISO 11737-2:2009)

EN ISO 13485:2016 EN ISO Quality

Date manageme
Medical devices - Quality management systems - 13485:2012
CEN 8/2016 expired nt system
Requirements for regulatory purposes (ISO (8/2016)
13485:2012)

EN ISO 14155:2011 Date Clinical

EN ISO expired investigatio
CEN Clinical investigation of medical devices for human 27/4/2012
14155:2011 (30/4/201 n
subjects – Good clinical practice (ISO 14155:2011) 2)

Risk
EN ISO 14971:2012 EN ISO Date
manageme
Medical devices - Application of risk management to 14971:2009 expired
CEN 30/08/2012 nt
medical devices (ISO 14971:2007, Corrected version (30/08/20
2007-10-01) 12)

EN 980:2008 Labelling
CEN 23/7/2008 EN 980:2003 31/5/2010 and
Symbol for use in the labeling of medical devices symbols

Technical
EN 1041:2008 Date information
Information supplied by the manufacturer of medical expired supplied by
CEN 19/2/2009 EN 1041:1998
31/8/201 the
devices
1 manufactur
e

EN ISO 14644 Clean room

Airborne Particulate Cleanliness Classes validation
CEN in Cleanrooms and Clean Zones –part 1: Classification 1/5/1999
of air cleanliness
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EN ISO 14644 Clean room

Airborne Particulate Cleanliness Classes validation
in Cleanrooms and Clean Zones –part 2: Specifications
CEN 15/9/200
for testing and monitoring to prove continued
compliance with ISO 14644-1

EN ISO 14644 Clean room

Airborne Particulate Cleanliness Classes validation
CEN 15/12/2005
in Cleanrooms and Clean Zones –part 3: Test methods

EN ISO 14644 Clean room

Airborne Particulate Cleanliness Classes validation
CEN in Cleanrooms and Clean Zones –part 4: Design, 2001
construction and start-up

EN ISO 14644 Clean room

Airborne Particulate Cleanliness Classes validation
CEN 8/2004
in Cleanrooms and Clean Zones –part 5: Operations

EN ISO 14644 Clean room

Airborne Particulate Cleanliness Classes validation
CEN 17/1/2008
in Cleanrooms and Clean Zones –part 6: Vocabulary

EN ISO 14644 Clean room

Airborne Particulate Cleanliness Classes validation
in Cleanrooms and Clean Zones –part 7: Separative
CEN 1/10/2004
enclosures (clean air hoods, gloveboxes, isolators,
mini-environments)

EN ISO 14644 Clean room

Airborne Particulate Cleanliness Classes validation
CEN in Cleanrooms and Clean Zones –part 8: Classification 15/8/2006
of airborne molecular contamination

ISO 14698-1:2003(en) Clean room

Cleanrooms and associated controlled environments — microbiolog
CEN 2003 ical testing
Biocontamination control --Biocontamination control,
Part 1: General principles and methods
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ISO 14698-2:2003(en) Clean room

CEN Cleanrooms and associated controlled environments-- 2003

Biocontamination control, Part 2: Evaluation and microbiolog
interpretation of biocontamination data ical testing

ASTM F1980 Accelerated

stability
Standard Guide for Accelerated Aging of Sterile Barrier 07-2011
study
Systems for Medical Devices

Approving
ASTM F899-07 the
biocompati
Standard Specification for Feb. 1, 2007.
bility of
Wrought Stainless Steels for Surgical Instrument surgical
needle

Approving
ASTM F1350 – 08 the
biocompati
Standard Specification for Published
bility of
June 2008.
Wrought 18Chromium-14Nickel-2.5Molybdenum stainless
Stainless Steel Surgical Fixation Wire (UNS S31673) steel 316
lvm

ASTM F138 − 13a Approving

the
Standard Specification for biocompati
November bility of
Wrought 18Chromium-14Nickel-2.5Molybdenum 2013 stainless
Stainless Steel Bar and Wire for Surgical Implants steel 316
(UNS S31673) lvm

MEDDEV 2 12-1 rev. 8 Vigilance

Guidelines January 2013
on a medical devices vigilance system

MEDDEV 2.12/2 rev2 Post

Guidelines on medical devices marketing
post market clinical follow-up studies January 2012 clinical
a guide for manufacturers and notified bodies follow up

MEDDEV 2.7.1 December Clinical

Guidelines on medical devicesClinical Evaluation 2009 Evaluation

Council Directive MDD( 93/42/EEC) 14 June 1993 on Preparation

5 September of technical
Medical Devices)and amendment 2007/47/EC on 2007 file
Medical Devices 5 September 2007 And
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formulation
of essential
requirment
s

Notified
NBOG BPG 2014-3 Bodies on
reporting of
Guidance for manufacturers and Notified Bodies on reporting of Nov 2014
Design
Design Changes and Changes of the Quality System Changes and
Changes

GMP
WHO guidelines requirement

REGULATION (EU) 2017/745 OF THE EUROPEAN

PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on
medical devices, amending Directive 2001/83/EC,
Regulation (EC) No 178/2002 and Regulation (EC)
No 1223/2009 and repealing Council Directives
90/385/EEC and 93/42/EEC

Signature:

Date of revision: 20/10/2017