EN 1041 :2008: Information supplied by the manufacturer of medical devices

Information supplied by the manufacturer of medical devices (includes Amendment
A1:2013)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references ……………………………………………………………………………………………………… 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 Requirements ………………………………………………………………………………………………………………… 6
4.1 General ………………………………………………………………………………………………………………………….. 6
4.2 Units, symbols and colours ……………………………………………………………………………………………. 6
4.3 Language and country identifiers …………………………………………………………………………………… 7
4.4 Dates ……………………………………………………………………………………………………………………………… 7
4.5 Device nomenclature ……………………………………………………………………………………………………… 7
4.5.1 Identifiers of nomenclature …………………………………………………………………………………………….. 7
4.5.2 Device common terms ……………………………………………………………………………………………………. 7
4.5.3 Batch code; lot number; batch number; lot code …………………………………………………………….. 7
5 Requirements for provision of information ……………………………………………………………………… 7
5.1 General ………………………………………………………………………………………………………………………….. 7
5.1.1 !Safe and effective use of the device” …………………………………………………………………………….. 7
5.1.2 !Address required under medical devices directives” ……………………………………………………… 7
5.2 Specific requirements …………………………………………………………………………………………………….. 8
5.2.1 Applicability …………………………………………………………………………………………………………………… 8
5.2.2 Accessibility ………………………………………………………………………………………………………………….. 8
5.2.3 Legibility ………………………………………………………………………………………………………………………… 8
5.2.4 Availability …………………………………………………………………………………………………………………….. 9
5.2.5 Security …………………………………………………………………………………………………………………………. 9
5.2.6 Changes to information provided ……………………………………………………………………………………. 9
6 Documentation ………………………………………………………………………………………………………………. 9
Annex A (informative) Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as
amended 10 A.1 Requirements and guidance for medical devices (Directive 93/42/EEC) … 10
A.2 Requirements and guidance for active implantable medical devices (Directive
90/385/EEC) ………………………………………………………………………………………………………………….. 16
Annex B (informative) Guidance on alternative labelling for instructions for use (IFU) ………………….. 20
B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC) ………………….. 21
B.2 Guidance on alternative labelling for active implantable medical devices (Directive
90/385/EEC) ………………………………………………………………………………………………………………….. 22
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EC ………………………………………………………………………… 23
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EC ………………………………………………………………………. 24
Bibliography ……………………………………………………………………………………………………………………………….. 25

Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates

DIN EN 15986:2011-05 (E)
Symbol for use in the labelling of medical devices – Requirements for labelling of
medical devices containing phthalates
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
1 Scope ……………………………………………………………………………………………………………………………..5
2 Terms and definitions ……………………………………………………………………………………………………..5
3 Requirements for usage ………………………………………………………………………………………………….5
4 Symbol labelling phthalates …………………………………………………………………………………………….6
Annex A (informative) Examples of uses of the symbol given in this European Standard ………………..7
Annex B (informative) Use of the negation symbol ………………………………………………………………………..10
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….11
Bibliography …………………………………………………………………………………………………………………………………12

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

Abstract

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

DIN EN ISO 18113-1:2013-01 (E)
In vitro diagnostic medical devices – Information supplied by the manufacturer
(labelling) – Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 6
2 Normative references …………………………………………………………………………………………………….. 6
3 Terms and definitions …………………………………………………………………………………………………….. 7
4 General requirements for information supplied by the manufacturer ……………………………… 22
4.1 General ………………………………………………………………………………………………………………………… 22
4.2 Language …………………………………………………………………………………………………………………….. 23
4.3 Symbols and identification colours ………………………………………………………………………………. 23
4.4 Values and nomenclature ……………………………………………………………………………………………… 23
4.5 Microbiological state …………………………………………………………………………………………………….. 23
4.6 Instructions for use ………………………………………………………………………………………………………. 23
4.7 Changes to the IVD medical device ……………………………………………………………………………….. 24
4.8 Disclosure of residual risks ………………………………………………………………………………………….. 24
4.9 Identification of components ………………………………………………………………………………………… 25
4.10 Assistance …………………………………………………………………………………………………………………… 25
Annex A (informative) Performance characteristics of IVD medical devices ………………………………….. 26
Bibliography ………………………………………………………………………………………………………………………………… 50
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” …….. 55

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

Abstract

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.

ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.

ISO 18113-2:2009 can also be applied to accessories.

ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

DIN EN ISO 18113-2:2013-01 (E)
In vitro diagnostic medical devices – Information supplied by the manufacturer
(labelli ng) – Part 2: In vitro diagnostic reagents for professional use (ISO 18113-
2:2009)
Contents Page
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 General ………………………………………………………………………………………………………………………….. 6
4.1 Essential requirements …………………………………………………………………………………………………… 6
4.2 Identification of kit components ……………………………………………………………………………………… 6
5 Content of the outer container label ……………………………………………………………………………….. 6
5.1 Manufacturer ………………………………………………………………………………………………………………….. 6
5.2 Identification of the IVD reagent ……………………………………………………………………………………… 6
5.3 Contents ………………………………………………………………………………………………………………………… 6
5.4 Intended use ………………………………………………………………………………………………………………….. 6
5.5 In vitro diagnostic use ……………………………………………………………………………………………………. 7
5.6 Storage and handling conditions ……………………………………………………………………………………. 7
5.7 Expiry date …………………………………………………………………………………………………………………….. 7
5.8 Warnings and precautions ……………………………………………………………………………………………… 7
6 Content of the immediate container label ………………………………………………………………………… 7
6.1 General provisions …………………………………………………………………………………………………………. 7
6.2 Manufacturer ………………………………………………………………………………………………………………….. 8
6.3 Identification of the IVD reagent ……………………………………………………………………………………… 8
6.4 Contents ………………………………………………………………………………………………………………………… 8
6.5 In vitro diagnostic use ……………………………………………………………………………………………………. 8
6.6 Storage and handling conditions ……………………………………………………………………………………. 8
6.7 Expiry date …………………………………………………………………………………………………………………….. 8
6.8 Warnings and precautions ……………………………………………………………………………………………… 8
7 Content of the instructions for use …………………………………………………………………………………. 9
7.1 Manufacturer ………………………………………………………………………………………………………………….. 9
7.2 Identification of the IVD reagent ……………………………………………………………………………………… 9
7.3 Intended use ………………………………………………………………………………………………………………….. 9
7.4 Principles of the examination method …………………………………………………………………………….. 9
7.5 Traceability of values assigned to calibrators and trueness-control materials …………………. 9
7.6 Components ………………………………………………………………………………………………………………… 10
7.7 Additional required equipment ……………………………………………………………………………………… 10
7.8 Reagent preparation …………………………………………………………………………………………………….. 10
7.9 Storage and shelf life after first opening ……………………………………………………………………….. 10
7.10 Warnings and precautions ……………………………………………………………………………………………. 10
7.11 Primary sample collection, handling and storage ………………………………………………………….. 11
7.12 Examination procedure ………………………………………………………………………………………………… 11
7.13 Control procedure ………………………………………………………………………………………………………… 11
7.14 Calculation of examination results ………………………………………………………………………………… 11
7.15 Interpretation of results ………………………………………………………………………………………………… 11
7.16 Performance characteristics …………………………………………………………………………………………. 11
7.17 Biological reference intervals ……………………………………………………………………………………….. 12
7.18 Limitations of the examination procedure …………………………………………………………………….. 12

7.19 Literature references ……………………………………………………………………………………………………. 12
Bibliography ……………………………………………………………………………………………………………………………….. 13
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” ……. 15

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

Abstract

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.

ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

ISO 18113-3:2009 can also be applied to accessories, where appropriate.

DIN EN ISO 18113-3:2013-01 (E)
In vitro diagnostic medical devices – Information supplied by the manufactur er
(labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-
3:2009)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 6
4 Essential requirements …………………………………………………………………………………………………… 6
5 Labels and marking ………………………………………………………………………………………………………… 6
5.1 General ………………………………………………………………………………………………………………………….. 6
5.2 Identification of the IVD instrument ………………………………………………………………………………… 6
6 Elements of the instructions for use ……………………………………………………………………………….. 6
7 Content of the instructions for use …………………………………………………………………………………. 7
7.1 Manufacturer ………………………………………………………………………………………………………………….. 7
7.2 Identification of the IVD instrument ………………………………………………………………………………… 7
7.3 Intended use ………………………………………………………………………………………………………………….. 7
7.4 Storage and handling ……………………………………………………………………………………………………… 8
7.5 Warnings and precautions ……………………………………………………………………………………………… 8
7.6 Instrument installation ……………………………………………………………………………………………………. 8
7.7 Theory of operation ………………………………………………………………………………………………………… 9
7.8 Functions ………………………………………………………………………………………………………………………. 9
7.9 Performance of the IVD instrument …………………………………………………………………………………. 9
7.10 Limitations of use …………………………………………………………………………………………………………. 10
7.11 Preparation prior to operation ………………………………………………………………………………………. 10
7.12 Operating procedure …………………………………………………………………………………………………….. 10
7.13 Control procedure ………………………………………………………………………………………………………… 10
7.14 Calculation of examination results ………………………………………………………………………………… 10
7.15 Special functions ………………………………………………………………………………………………………….. 11
7.16 Emergency primary samples ………………………………………………………………………………………… 11
7.17 Shut-down procedure …………………………………………………………………………………………………… 11
7.18 Disposal information …………………………………………………………………………………………………….. 11
7.19 Maintenance …………………………………………………………………………………………………………………. 11
7.20 Troubleshooting …………………………………………………………………………………………………………… 12
Bibliography ………………………………………………………………………………………………………………………………… 13
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” …….. 14

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

Abstract

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.

ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.

ISO 18113-4:2009 can also be applied to accessories, where appropriate.

ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

DIN EN ISO 18113-4:2013-01 (E)
In vitro diagnostic medical devices – Information supplied by the manufacturer (label
ling) – Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 General ………………………………………………………………………………………………………………………….. 6
4.1 Essential requirements …………………………………………………………………………………………………… 6
4.2 Identification of kit components ……………………………………………………………………………………… 6
4.3 Presentation of the instructions for use ………………………………………………………………………….. 6
5 Content of the outer container label ……………………………………………………………………………….. 6
5.1 Manufacturer ………………………………………………………………………………………………………………….. 6
5.2 Identification of the IVD reagent ……………………………………………………………………………………… 6
5.3 Contents ………………………………………………………………………………………………………………………… 7
5.4 Intended use ………………………………………………………………………………………………………………….. 7
5.5 In vitro diagnostic use ……………………………………………………………………………………………………. 7
5.6 Storage and handling conditions ……………………………………………………………………………………. 7
5.7 Expiry date …………………………………………………………………………………………………………………….. 7
5.8 Warnings and precautions ……………………………………………………………………………………………… 8
6 Content of the immediate container label ………………………………………………………………………… 8
6.1 General provisions …………………………………………………………………………………………………………. 8
6.2 Manufacturer ………………………………………………………………………………………………………………….. 8
6.3 Identification of the IVD reagent ……………………………………………………………………………………… 8
6.4 Contents ………………………………………………………………………………………………………………………… 8
6.5 In vitro diagnostic use ……………………………………………………………………………………………………. 8
6.6 Storage and handling conditions ……………………………………………………………………………………. 9
6.7 Expiry date …………………………………………………………………………………………………………………….. 9
6.8 Warnings and precautions ……………………………………………………………………………………………… 9
7 Content of the instructions for use …………………………………………………………………………………. 9
7.1 Manufacturer ………………………………………………………………………………………………………………….. 9
7.2 Identification of the IVD reagent ……………………………………………………………………………………… 9
7.3 Intended use ………………………………………………………………………………………………………………….. 9
7.4 Principles of the examination method …………………………………………………………………………… 10
7.5 Components ………………………………………………………………………………………………………………… 10
7.6 Additional required equipment ……………………………………………………………………………………… 10
7.7 Reagent preparation …………………………………………………………………………………………………….. 10
7.8 Storage and shelf life after first opening ……………………………………………………………………….. 10
7.9 Warnings and precautions ……………………………………………………………………………………………. 10
7.10 Primary sample collection, handling and storage ………………………………………………………….. 11
7.11 Examination procedure ………………………………………………………………………………………………… 11
7.12 Control procedure ………………………………………………………………………………………………………… 11
7.13 Reading of examination results …………………………………………………………………………………….. 11
7.14 Interpretation of results ………………………………………………………………………………………………… 11
7.15 Performance characteristics …………………………………………………………………………………………. 11

7.16 Biological reference intervals ………………………………………………………………………………………. 12
7.17 Limitations of examination procedure ………………………………………………………………………….. 12
7.18 Literature references ……………………………………………………………………………………………………. 12
Bibliography ……………………………………………………………………………………………………………………………….. 13
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” ……. 15

In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

Abstract

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.

ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.

ISO 18113-5:2009 can also be applied to accessories.

DIN EN ISO 18113-5:2013-01 (E)
In vitro diagnostic medical devices – Information supplied by the manufacturer
(labelling ) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 6
4 Essential requirements …………………………………………………………………………………………………… 6
5 Labels and marking ………………………………………………………………………………………………………… 6
5.1 General ………………………………………………………………………………………………………………………….. 6
5.2 Identification of the IVD instrument ………………………………………………………………………………… 6
6 Elements of the instructions for use ……………………………………………………………………………….. 7
7 Content of the instructions for use …………………………………………………………………………………. 7
7.1 Manufacturer ………………………………………………………………………………………………………………….. 7
7.2 Identification of the IVD instrument ………………………………………………………………………………… 7
7.3 Intended use ………………………………………………………………………………………………………………….. 8
7.4 Storage and handling ……………………………………………………………………………………………………… 8
7.5 Warnings and precautions ……………………………………………………………………………………………… 8
7.6 Instrument installation ……………………………………………………………………………………………………. 8
7.7 Principles of measurement …………………………………………………………………………………………….. 9
7.8 Performance of the IVD instrument …………………………………………………………………………………. 9
7.9 Limitations of use …………………………………………………………………………………………………………… 9
7.10 Preparation prior to operation ………………………………………………………………………………………… 9
7.11 Operating procedure ………………………………………………………………………………………………………. 9
7.12 Control procedure ………………………………………………………………………………………………………… 10
7.13 Reading of examination results …………………………………………………………………………………….. 10
7.14 Special functions ………………………………………………………………………………………………………….. 10
7.15 Shut-down procedure …………………………………………………………………………………………………… 10
7.16 Disposal information …………………………………………………………………………………………………….. 10
7.17 Maintenance …………………………………………………………………………………………………………………. 11
7.18 Troubleshooting …………………………………………………………………………………………………………… 11
7.19 Follow-up action …………………………………………………………………………………………………………… 11
Bibliography ………………………………………………………………………………………………………………………………… 12
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” …….. 13