ISO/PRF TS 16775

Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2

Emballages des dispositifs médicaux stérilisés au stade terminal -- Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2

General Information

• Status: Published
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: ISO/TC 198 - Sterilization of health care products
• Drafting Committee: ISO/TC 198/WG 7 - Packaging
• Current Stage: 5060 - Close of voting Proof returned by Secretariat
• Start Date: 21-Jul-2021
• Completion Date: 21-Jul-2021

RELATIONS

• Revised: ISO/TS 16775:2014 - Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2
• Effective Date: 23-Apr-2020

Standards Content (sample)

TECHNICAL ISO/TS
SPECIFICATION 16775
Second edition
Packaging for terminally sterilized
medical devices — Guidance on the
application of ISO 11607-1 and ISO
11607-2
Emballages des dispositifs médicaux stérilisés au stade terminal —
Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO
11607-2
PROOF/ÉPREUVE
Reference number
ISO/TS 16775:2021(E)
ISO 2021
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ISO/TS 16775:2021(E)
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© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
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ISO/TS 16775:2021(E)
Contents Page

Foreword ......................................................................................................................................................................................................................................vii

Introduction ............................................................................................................................................................................................................................viii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Guidance on Clauses 1-4 of ISO 11607-1:2019 and ISO 11607-2:2019 .......................................................2

4.1 Scope (ISO 11607-1:2019, 1 and ISO 11607-2:2019, 1) ..................................................................................... 2

4.1.1 Intent .......................................................................................................................................................................................... 2

4.1.2 Guidance.................................................................................................................................................................................. 2

4.2 Normative references (ISO 11607-1:2019, Clause 2 and ISO 11607-2:2019, Clause 2) ......... 3

4.2.1 Intent .......................................................................................................................................................................................... 3

4.2.2 Guidance.................................................................................................................................................................................. 3

4.3 Terms and definitions (ISO 11607-1:2019, Clause 3 and ISO 11607-2:2019, Clause 3) ........ 3

4.3.1 Intent .......................................................................................................................................................................................... 3

4.3.2 Guidance.................................................................................................................................................................................. 4

4.4 Quality and risk management (ISO 11607-1:2019, 4.1, 4.2 and ISO 11607-2:2019,

4.1, 4.2) .......................................................................................................................................................................................................... 4

4.4.1 Intent .......................................................................................................................................................................................... 4

4.4.2 Guidance.................................................................................................................................................................................. 4

4.5 Sampling (ISO 11607-1:2019, 4.3 and ISO 11607-2:2019, 4.3) ................................................................... 6

4.5.1 Intent .......................................................................................................................................................................................... 6

4.5.2 Guidance.................................................................................................................................................................................. 6

4.6 Test methods (ISO 11607-1:2019, 4.4 and ISO 11607-2:2019, 4.4) ......................................................... 7

4.6.1 Intent .......................................................................................................................................................................................... 7

4.6.2 Guidance.................................................................................................................................................................................. 7

4.7 Documentation (ISO 11607-1:2019, 4.5 and ISO 11607-2:2019, 4.5) ................................................... 9

4.7.1 Intent .......................................................................................................................................................................................... 9

4.7.2 Guidance.................................................................................................................................................................................. 9

5 Guidance on Clause 5.1.1 of ISO 11607-1:2019 .................................................................................................................... 9

5.1 General requirements for materials, preformed sterile barrier systems and sterile

barrier systems (ISO 11607-1:2019, 5.1.1 and 5.1.2) ........................................................................................... 9

5.1.1 Intent .......................................................................................................................................................................................... 9

5.1.2 Guidance...............................................................................................................................................................................10

5.2 Conditions for production and handling (ISO 11607-1:2019, 5.1.3 and 5.1.4)............................10

5.2.1 Intent .......................................................................................................................................................................................10

5.2.2 Guidance...............................................................................................................................................................................10

5.3 Source, history and traceability of materials (ISO 11607-1:2019, 5.1.5) ..........................................11

5.3.1 Intent .......................................................................................................................................................................................11

5.3.2 Guidance...............................................................................................................................................................................11

5.4 Properties to be evaluated (ISO 11607-1:2019, 5.1.6) ......................................................................................11

5.4.1 Intent .......................................................................................................................................................................................11

5.4.2 Guidance...............................................................................................................................................................................11

5.5 General performance requirements for materials (ISO 11607-1:2019, 5.1.7 and 5.1.8) ....12

5.5.1 Intent .......................................................................................................................................................................................12

5.5.2 Guidance...............................................................................................................................................................................12

5.6 Additional requirements for sterile barrier systems and preformed sterile barrier

systems (ISO 11607-1:2019, 5.1.9) ....................................................................................................................................15

5.6.1 Intent .......................................................................................................................................................................................15

5.6.2 Guidance...............................................................................................................................................................................15

5.7 Reusable sterile barrier systems (ISO 11607-1:2019, 5.1.10, 5.1.11 and 5.1.12) .....................17

5.7.1 Intent .......................................................................................................................................................................................17

5.7.2 Guidance...............................................................................................................................................................................17

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5.8 Microbial barrier properties (ISO 11607-1:2019, 5.2) .....................................................................................17

5.8.1 Intent .......................................................................................................................................................................................17

5.8.2 Guidance...............................................................................................................................................................................17

5.9 Compatibility with the sterilization process (ISO 11607-1:2019, 5.3) ...............................................17

5.9.1 Intent .......................................................................................................................................................................................17

5.9.2 Guidance...............................................................................................................................................................................18

5.10 Labelling system (ISO 11607-1:2019, 5.4) ..................................................................................................................18

5.10.1 Intent .......................................................................................................................................................................................18

5.10.2 Guidance...............................................................................................................................................................................19

5.11 Storage and transport of materials and preformed sterile barrier systems

(ISO 11607-1:2019, 5.5) ..............................................................................................................................................................20

5.11.1 Intent .......................................................................................................................................................................................20

5.11.2 Guidance...............................................................................................................................................................................20

5.12 Design and development (ISO 11607-1:2019, 6.1.1)..........................................................................................21

5.12.1 Intent .......................................................................................................................................................................................21

5.12.2 Guidance...............................................................................................................................................................................21

5.13 Aseptic presentation (ISO 11607-1:2019, 6.1.2) ....................................................................................................22

5.13.1 Intent .......................................................................................................................................................................................22

5.13.2 Guidance...............................................................................................................................................................................22

5.14 Physical protection (ISO 11607-1:2019, 6.1.3 and 6.1.4) ...............................................................................24

5.14.1 Intent .......................................................................................................................................................................................24

5.14.2 Guidance...............................................................................................................................................................................24

5.15 Sterilization compatibility (ISO 11607-1:2019, 6.1.5) ......................................................................................24

5.15.1 Intent .......................................................................................................................................................................................24

5.15.2 Guidance...............................................................................................................................................................................24

5.16 Maintenance of Sterility (ISO 11607-1:2019, 6.1.6 and 6.1.7) ...................................................................25

5.16.1 Intent .......................................................................................................................................................................................25

5.16.2 Guidance...............................................................................................................................................................................25

5.17 Requirements for multi-layer packaging (ISO 11607-1:2019, 6.1.8) ...................................................26

5.17.1 Intent .......................................................................................................................................................................................26

5.17.2 Guidance...............................................................................................................................................................................26

5.18 Packaging families (ISO 11607-1:2019, 6.1.9) .........................................................................................................26

5.18.1 Intent .......................................................................................................................................................................................26

5.18.2 Guidance...............................................................................................................................................................................26

5.19 Design process (ISO 11607-1:2019, 6.2.1) ..................................................................................................................28

5.19.1 Intent .......................................................................................................................................................................................28

5.19.2 Guidance...............................................................................................................................................................................28

5.20 Design inputs (ISO 11607-1:2019, 6.2.2 and 6.2.3) .............................................................................................29

5.20.1 Intent .......................................................................................................................................................................................29

5.20.2 Guidance...............................................................................................................................................................................29

5.21 Sterile fluid path (ISO 11607-1:2019, 6.2.4, 6.2.5) ...............................................................................................31

5.21.1 Intent .......................................................................................................................................................................................31

5.21.2 Guidance...............................................................................................................................................................................31

5.22 Usability evaluation for aseptic presentation (ISO 11607-1:2019, 7.1, 7.2 and 7.3) ..............32

5.22.1 Intent .......................................................................................................................................................................................32

5.22.2 Guidance...............................................................................................................................................................................32

5.23 Leveraging usability evaluations (ISO 11607-1:2019, 7.4) ...........................................................................33

5.23.1 Intent .......................................................................................................................................................................................33

5.23.2 Guidance...............................................................................................................................................................................33

5.24 Usability evaluation failures (ISO 11607-1:2019, 7.5) ......................................................................................33

5.24.1 Intent .......................................................................................................................................................................................33

5.24.2 Guidance...............................................................................................................................................................................33

5.24.3 Guidance on formative and summative studies .................................................................................34

5.25 Packaging system performance and stability (ISO 11607-1:2019, 8.1) .............................................35

5.25.1 Intent .......................................................................................................................................................................................35

5.25.2 Guidance...............................................................................................................................................................................35

5.26 Packaging system performance testing (ISO 11607-1:2019, 8.2) ...........................................................36

5.26.1 Intent .......................................................................................................................................................................................36

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5.26.2 Guidance...............................................................................................................................................................................37

5.27 Stability testing (ISO 11607-1:2019, 8.3) .....................................................................................................................38

5.27.1 Intent .......................................................................................................................................................................................38

5.27.2 Guidance...............................................................................................................................................................................38

5.28 Packaging system validation and changes (ISO 11607-1:2019, 9.1).....................................................39

5.28.1 Intent .......................................................................................................................................................................................39

5.28.2 Guidance...............................................................................................................................................................................39

5.29 Change control (ISO 11607-1:2019, 9.2) ......................................................................................................................40

5.29.1 Intent .......................................................................................................................................................................................40

5.29.2 Guidance...............................................................................................................................................................................40

5.30 Revalidations (ISO 11607-1:2019, 9.3, 9.4, and 9.5) ...........................................................................................40

5.30.1 Intent .......................................................................................................................................................................................40

5.30.2 Guidance...............................................................................................................................................................................40

5.31 Inspection immediately prior to aseptic presentation (ISO 11607-1:2019, Clause 10) ......40

5.31.1 Intent .......................................................................................................................................................................................40

5.31.2 Guidance...............................................................................................................................................................................41

5.32 Information to be provided (ISO 11607-1:2019, Clause 11) .......................................................................41

5.32.1 Intent .......................................................................................................................................................................................41

5.32.2 Guidance...............................................................................................................................................................................41

6 Guidance on Clauses 5-8 of ISO 11607-2:2019 ..................................................................................................................42

6.1 General Clauses 1-4 of ISO 11607-2:2019 ...................................................................................................................42

6.2 Validation of packaging processes – general requirements (ISO 11607-2:2019,

5.1.1 and 5.1.2) .................. ...................................................................................................................................................................42

6.2.1 Intent .......................................................................................................................................................................................42

6.2.2 Guidance...............................................................................................................................................................................42

6.3 Process specification (ISO 11607-2:2019, 5.1.3) ...................................................................................................42

6.3.1 Intent .......................................................................................................................................................................................42

6.3.2 Guidance...............................................................................................................................................................................42

6.4 Process validation of packaging families (ISO 11607-2:2019, 5.1.4) ...................................................43

6.4.1 Intent .......................................................................................................................................................................................43

6.4.2 Guidance...............................................................................................................................................................................43

6.5 Installation qualification (ISO 11607-2:2019, 5.2) ...............................................................................................44

6.5.1 Intent .......................................................................................................................................................................................44

6.5.2 Guidance...............................................................................................................................................................................44

6.6 Operational qualification (ISO 11607-2:2019, 5.3)..............................................................................................45

6.6.1 Intent .......................................................................................................................................................................................45

6.6.2 Guidance...............................................................................................................................................................................45

6.7 Performance qualification (ISO 11607-2:2019, 5.4) ...........................................................................................46

6.7.1 Intent .......................................................................................................................................................................................46

6.7.2 Guidance...............................................................................................................................................................................46

6.8 Formal approval of the process validation (ISO 11607-2:2019, 5.5) ....................................................47

6.8.1 Intent .......................................................................................................................................................................................47

6.8.2 Guidance...............................................................................................................................................................................47

6.9 Process control and monitoring (ISO 11607-2:2019, 5.6) .............................................................................47

6.9.1 Intent .......................................................................................................................................................................................47

6.9.2 Guidance...............................................................................................................................................................................47

6.10 Process changes and revalidation (ISO 11607-2:2019, 5.7).........................................................................48

6.10.1 Intent .......................................................................................................................................................................................48

6.10.2 Guidance...............................................................................................................................................................................48

6.11 Assembly (ISO 11607-2:2019, Clause 6) .......................................................................................................................49

6.11.1 Intent .......................................................................................................................................................................................49

6.11.2 Guidance...............................................................................................................................................................................49

6.12 Use of reusabl
...