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Packaging Standards Medical Device Manufacturers Need to Know

General, ISO, and ASTM standards support patient protection at the highest level.

Kassandra Kania

March 9, 2023

8 Min Read
Medical-device-GettyImages-511535838-ftd.jpg
Brendan Delany / Getty Images

Standards specify and evaluate medical device design and performance requirements, ensuring the integrity of the finished product and its packaging. While the sheer number of ISO and ASTM documents can seem overwhelming — especially when it comes to testing and sterilization standards — this well-organized list makes it easier to find the appropriate standard and/or guidance for your products.

 

General Standards

Current Good Manufacturing Practice Requirements for Combination Products

USP <1207> Container Closure Integrity Testing

Corrective and Preventive Actions (CAPAs)

SPMC Standards and Test Methods  (Sterilization Packaging Manufacturers Council)

ANSI/AAMI HE75:2009 (R2018) Human factors engineering - Design of medical devices

The Global Unique Device Identification Database (GUDID): Guidance for Industry

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

IMDRF/GRRP WG/N52 FINAL:2019 Principles of Labelling for Medical Devices and IVD Medical Devices

 

ISO Standards

ISO 10993-18:2020 Biological Evaluation of Medical Devices — Part 18: Chemical Characterization of Medical Device Materials Within a Risk Management Process

ISO 11137-1: 2006 Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

ISO 11137-2: 2013 Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose

ISO 11137-3: 2017 Sterilization of Health Care Products - Radiation – Part 3: Guidance on Dosimetric Aspects of Development, Validation and Routine Control

ISO 11139 Sterilization of Health Care Products

ISO 11607:2019 Packaging for Terminally Sterilized Medical Devices

ISO TC 16775: 2021 Packaging for Terminally Sterilized Medical Devices - Guidance on the Application of ISO 11607-1 and ISO 11607-2

ISO 13485:2016 Quality Management System for Medical Devices

ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices

ISO 17665-1:2006 Sterilization of Health Care Products - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

ISO/TS 17665-2:2009 Sterilization of Health Care Products - Part 2: Guidance on the Application of ISO 17665

ISO/TS 17665-3:2013(en) - Part 3: Guidance on the Designation of a Medical Device to a Product Family and Processing Category for Steam Sterilization

ISO 24971:2020 Medical Devices - Guidance on the Application of ISO 14971

ISO/TS 22421:2021 Sterilization of Health Care Products - Common Requirements for Sterilizers for Terminal Sterilization of Medical Devices in Health Care Facilities

ISO TC198/WG7 Sterilization of Health Care Products - Packaging

ISO/IEC 62366-1:2015 Medical Devices - Part 1: Application of Usability Engineering to Medical Devices

ISO 3864-1:2011 Graphical Symbols - Safety Colours and Safety Signs - Part 1: Design Principles for Safety Signs and Safety Markings

ISO 8601-1:2019 Date and Time - Representations for Information iInterchange - Part 1: Basic Rules

ISO 8601-2:2019 Date and time - Representations for information interchange - Part 2: Extensions

ISO 15223-1:2016 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements

ISO 14971:2019 Medical devices - Application of Risk Management to Medical Devices

lEC 62366-1:2015 Medical Devices - Part 1: Application of the Usability Engineering Process to Medical Devices

ISO/IEC 646:1991 Information Technology - ISO 7-bit Coded Character Set for Information Interchange

ISO/IEC 15415:2011 Information Technology - Automatic Identification and Data Capture Techniques - Bar Code Symbol Print Quality Test Specification - Two-Dimensional Symbols

ISO/IEC 15416:2016 Automatic Identification and Data Capture Techniques - Bar code Print Quality Test Specification - Linear Symbols

ISO/IEC 15426-1:2006 Information Technology - Automatic Identification and Data Capture Techniques - Bar Code Verifier Conformance Specification - Part I: Linear Symbols

ISO/IEC 15426-2:2015 Information Technology - Automatic Identification and Data Capture Techniques - Bar Code Verifier Conformance Specification - Part 2: Two-Dimensional Symbols

ISO/IEC 15459-2:2015 Information technology - Automatic Identification and Data Capture Techniques - Unique Identification - Part 2: Registration Procedures

ISO/IEC 15459-4:2014 Information Technology - Automatic Identification and Data Capture Techniques - Unique Identification - Part 4: Individual Products and Product Packages

ISO/IEC 15459-6:2014 Information Technology - Automatic Identification and Data Capture Techniques - Unique Identification - Part 6: Groupings

ISO/IEC 16022:2006 Information Technology - Automatic Identification and Data Capture Techniques - Data Matrix Bar Code Symbology Specification

ISO/IEC TR 29158:2011 Information Technology - Automatic Identification and Data Capture Techniques - Direct Part Mark (DPM) Quality Guideline

ISO/IEC 18000-6:2013 Information Technology - Radio Frequency Identification for Item Management - Part 6: Parameters for Air Interface Communications at 860 MHz to 960 MHz

ISO 18113:2009 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer (Labelling) - Part 1: Terms, Definitions and General Requirements

ISO 18113:2009 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer (Labelling) - Part 2: In Vitro Diagnostic Reagents for Professional Use

 

ASTM Standards (reviewed every five years)

ASTM D4169 -16: Standard Practice for Performance Testing of Shipping Containers and System

ISTA 2a: Partial Simulation Performance Tests

ASTM D3078-02 (2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F1140/F1140M-13(2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications

ASTM F1327:1998 Standard Terminology Relating to Barrier Materials for Medical Packaging

ASTM F1608:2000 Standard Test Method for Microbial Ranking Porous Packaging Materials (Exposure Chamber Method)

ASTM-F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection (FDA Recognized Consensus Standard)

ASTM-F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (FDA Recognized Consensus Standard)

ASTM-F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM F2054-00 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

ASTM F2095-07(2021) Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates

ASTM-F2096-01 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Leak Test)  (FDA Recognized Consensus Standard)

ASTM F2096-11(2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

ASTM F2097-01 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products

ASTM F2097-20: Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ASTM F2227-13: Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method (FDA Recognized Consensus Standard)

ASTM F2228-13: Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method (FDA Recognized Consensus Standard)

ASTM F2338-09 (2013); Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method (FDA Recognized Consensus Standard)

ASTM F2391-05 (2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas (FDA Recognized Consensus Standard)

ASTM F2638-12e1 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

ASTM F3004-13e1 Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound

ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration

ASTM D3078-02 (2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission (FDA Recognized Consensus Standard)

ASTM F3169-16 Leak Detection in Blister Packaging by Vacuum Deflection Method by Laser Measurement

ASTM F3287-17 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method

Whole Package Microbial Challenge Integrity Testing

 

Standards in China

Provisions for Medical Device Standards

National Standard GB/T 19633 series (Part 1-2, identical to ISO 11607) — Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems; Part 2: Validation requirements for forming, sealing and assembly processes

Sectoral Standard YY/T 0698 series (Part 1-10, converted from EN868 series) — Packaging materials for terminally sterilized medical devices — Requirements and test methods

Sectoral Standard YY/T 0681 series (Part 1-18, converted from ASTM related standards) — Test methods for sterile medical device package

Sectoral Standard YY/T 0466 series (Part 1-2, identical to ISO 15223) — Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied

 

Standards in Japan

MHLW Ministerial Ordinance No. 169 (MHLW MO169) — The Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics

About the Author(s)

Kassandra Kania

Freelance Writer

Kassandra Kania is a freelance writer based in Charlotte, NC. She has written extensively about healthcare packaging for a variety of publications.

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