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Standards Applicable to the Packaging of Medical Devices.                                                              

 

International Standards Organisation

 

ISO 7197 (1997-11-01)

Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts and Components (Second Edition)

 

EN ISO 7864 (1995-01-01)

Sterile Hypodermic Needles for Single Use (ISO 7864: 1993)

 

EN ISO 7885 (2000-12-01)

Sterile Dental Injection Needles for Single Use (ISO 7885: 2000)

 

EN ISO 7886-1 (1997-05-01)

Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use

Note: Technical Corrigendum 1: 1995

 

EN ISO 7886-2 (1997-09-01)

Sterile Hypodermic Syringes for Single Use - Part 2: Syringes for Use with Power-Driven Syringe Pumps (ISO 7886-2: 1996)

 

EN ISO 8537 (1994-07-01)

Sterile Single-Use Syringes, with or Without Needle, for Insulin

Note: Amendment A1: 2000

 

ISO 9000 (2000-12-15)

Quality Management Systems - Fundamentals and Vocabulary (Second Edition; Supersedes ISO 9000-1:1994 and ISO 8402:1994)

 

ISO 9001 (2000-12-15)

Quality Management Systems – Requirements (Third Edition; Supersedes ISO 9002:1994 and ISO 9003:1994)

 

ISO 9002 (1994-07-01)

Quality Systems - Model for Quality Assurance in Production, Installation and Servicing (Second Edition)

 

ISO 9004 (2000-12-15)

Quality Management Systems - Guidelines for Performance Improvements (Second Edition; Supersedes ISO 9004-1:1994)

 

ISO 10282 (2002-09-15)

Single-Use Sterile Surgical Rubber Gloves – Specification (Edition 2)

 

EN ISO 10555-1 (1996-08-01)

Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements

Note: Amendment A1: 1999; ISO 10555-1:1995

 

EN ISO 10555-2 (1997-07-01)

Sterile, single-use intravascular catheters Part 2: Angiographic catheters

Note: ISO 10555-2:1996; corrigendum July 2002

 

EN ISO10555-3 (1997-07-01)

Sterile, single-use intravascular catheters Part 3: Central venous catheters

Note: ISO10555-3: 1996; corrigendum July 2002

 

EN ISO 10555-4 (1997-07-01)

Sterile, single-use intravascular catheters Part 4: Balloon dilatation catheters

Note: ISO10555-4: 1996; corrigendum July 2002

 

EN ISO 10555-5 (1997-07-01)

Sterile, single-use intravascular catheters Part 5: Over-needle peripheral catheters

Note: amendment A1: 2000

 

EN ISO 11070 (1999-04-01)

Sterile, Single-Use Intravascular Catheter Introducers (ISO 11070:1998)

 

ISO/DIS 11607-1 (2004-04-22) Rev 04

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1:

REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

 

ISO 13485 (2003-07-15)

Medical Devices Quality Management Systems Requirements for regulatory purposes (Second Edition)

 

ISO 13488 (1996-12-15)

Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9002 (First Edition)

 

EN ISO 14630 (1997-11-01)

Non-active surgical implants. General requirements (ISO 14630:1997) 

 

ISO/TR 14969:2004

Medical devices Quality management systems Guidance on the application of ISO 13485:2003 (First Edition; Replaces ISO14969:1999)

 

ISO 14971  

MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

 

ISO 14972 (1998-12-15)

Sterile Obturators for Single Use with Over needle Peripheral Intravascular Catheters (First Edition)

 

ISO 15223 (2000-04-15)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

Note: Amendment 1: 8/01/2002; Amendment 2: 02/15/2004

 

European Standards

 

CEN EN556-1 (2001-10-01)

Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile"- Part 1: Requirements for Terminally Sterilized Medical Devices (Supersedes EN 556: 1994)

 

CEN EN556-2 (2003-12-01)

Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices

 

EN 868 - 1,1997-02-01, Packaging materials and systems for medical devices which are to be sterilized. Part 1: General requirements and test methods

 

EN 868 – 2, Sterilization wrap. Requirements and test methods.

 

EN 868 – 3, Paper for use in the manufacture of paper bags and in the manufacture of pouches and reels. Requirements and test methods.

 

EN 868 – 4, Paper bags. Requirements and test methods.

 

EN 868 – 5, Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods.

 

EN 868 – 6, Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods.

 

EN 868 – 7, Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation.

Requirements and test methods.

 

EN 868 – 8, Re-usable sterilization containers for steam sterilizers conforming to EN 285.Requirements and test methods.

 

EN 868 – 9, Nonwoven uncoated materials of high density polyethylene fibres (Nonwoven HDPE) for the use in manufacture of pouches, reels, and lids. Requirements and test methods.

 

EN 868 –10, Adhesive coated Nonwoven materials of high density polyethylene fibres (HDPE) for the use in manufacture of pouches, reels and lids. Requirements and test methods

 

CEN EN 980  

GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES

 

CEN EN 1041  

INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES

 

CEN EN 1615 (1997-02-01)

Sterile Enteral Feeding Catheters and Giving Sets for Single Use

 

CEN EN 1616 (1997-12-01)

AMD 1 Sterile Urethral Catheters for Single Use (AMD 1)

 

CEN EN 1617 (1997-02-01)

Sterile Drainage Catheters and Accessory Devices for Single Use

 

CEN EN 1782 (1998-03-01) Tracheal tubes and connectors

 

EN 1819 (1997-10-01) Laryngoscopes for tracheal intubation. Particular requirements

 

EN 12006-1 (1999-07-01)

Non active surgical implants. Particular requirements for cardiac and vascular implants.

Part 1: Heart valve substitutes

 

EN 12006-2 (1998-02-01)

Non active surgical implants. Particular requirements for cardiac and vascular implants.

Part 2: Vascular prostheses including cardiac valve conduits

 

EN 12006-3 (1998-11-01)

Non active surgical implants. Particular requirements for cardiac and vascular implants.

Part 3: Endovascular devices

 

EN 12010 (1998-02-01)

Non-active surgical implants. Joint replacement implants. Particular requirements

 

EN 12011 (1998-01-01)

Instrumentation to be used in association with non-active surgical implants. General requirements

 

EN 12342 (1998-06-01)

Breathing tubes intended for use with anaesthetic apparatus and ventilators

 

CEN EN 12439 (1998-10-01)

Sterile Rectal Catheters for Single Use

 

EN 12563 (1998-12-01)

Non-active surgical implants. Joint replacement implants. Specific requirements for hip joint replacement implants

 

EN 12564 (1998-12-01)

Non-active surgical implants. Joint replacement implants. Specific requirements for knee joint replacement implants

 

EN 46001 and EN 46002withdrawn, see ISO 13485:2003

 

EN 46003 (1999-04-01)

Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003

 

CENELEC EN 50103(1995-01-01)

Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the Active (Including Active Implantable) Medical Device Industry

 

ASTM Standard Test Methods 

ASTM F88

Standard Test Method for Seal Strength for Flexible Barrier Materials.

 

F1585-00

Standard Guide for Integrity Testing of Porous Barrier Medical Packages.

F1608-00

Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method). 

F1886-98

Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection. 

F1929-98

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.

F1980-02

Standard Guide for Accelerated Aging of Sterile Medical Device Packages.

F2054-00

Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates.

F2095-01

Standard Test Methods for Pressure Decay Leak test for Nonporous Flexible Packages with and without Restraining Plates.

F2096-01

Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test).

F2097-01

Standard Guide for Design and Evaluation of Primary Packaging for Medical Products.

F2217-02

Standard Practice for Coating/Adhesive Weight Determination.

F2227-02

Standard Test Method for Non-Destructive Detection of Leaks in Non-Sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method.

F2228-02

Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging which Incorporates Porous Barrier Material by CO2 Tracer Gas Method.

F2251-03

Standard Test Method for Thickness Measurement of Flexible Packaging Material.      

 

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