Medical Pack Solutions 

Standards and

Test Methods

ISO Standards

ISO 7197 (1997-11-01) Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts and Components (Second Edition)
ISO 7864 (1995-01-01) Sterile Hypodermic Needles for Single Use (ISO 7864: 1993)
ISO 7885 (2000-12-01) Sterile Dental Injection Needles for Single Use (ISO 7885: 2000)
ISO 7886-1 (1997-05-01) Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use Note: Technical Corrigendum 1: 1995
ISO 7886-2 (1997-09-01) Sterile Hypodermic Syringes for Single Use - Part 2: Syringes for Use with Power Driven Syringe Pumps
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 每 Requirements (Third Edition
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
ISO 10282 (2002-09-15) Single-Use Sterile Surgical Rubber Gloves 每 Specification (Edition 2)
ISO 10555-1 (1996-08-01) Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements            Note: Amendment A1: 1999
ISO 10555-2 (1997-07-01) Sterile, single-use intravascular catheters Part 2: Angiographic catheters Note: ISO 10555-2:1996; corrigendum July 2002
ISO10555-3 (1997-07-01) Sterile, single-use intravascular catheters Part 3: Central venous catheters          Note: ISO10555-3: 1996; corrigendum July 2002
ISO 10555-4 (1997-07-01) Sterile, single-use intravascular catheters Part 4: Balloon dilatation catheters        Note: ISO10555-4: 1996; corrigendum July 2002
ISO 10555-5 (1997-07-01) Sterile, single-use intravascular catheters Part 5: Over-needle peripheral catheters. Note: amendment A1: 2000
ISO 11070 (1999-04-01) Sterile, Single-Use Intravascular Catheter Introducers (ISO 11070:1998)
ISO 11607-1: 2006 Packaging for terminally sterilised medical devices-PART 1: Requirements for materials, sterile barrier systems, and packaging 
ISO 11607-1:2006 Packaging for terminally sterilised medical devices-PART 2: Validation requirements for forming, sealing, and assembly processes
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)
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.

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 
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 forsterilization 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.
EN 980   GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
EN 1041   INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES
EN 1615 (1997-02-01) Sterile Enteral Feeding Catheters and Giving Sets for Single Use
EN 1616 (1997-12-01) AMD 1 Sterile Urethral Catheters for Single Use (AMD 1)
EN 1617 (1997-02-01) Sterile Drainage Catheters and Accessory Devices for Single Use
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
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 46003 (1999-04-01) Quality systems. Medical devices. Particular requirements for the application of EN ISO
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 Test Methods 

F88 / F88M-09 Standard Test Method for Seal Strength for Flexible Barrier Materials.
F1585-00 Standard Guide for Integrity Testing of Porous Barrier Medical Packages. Withdrawn 2006
F1608-00 (2009) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method). 
F1886 / F1886M-09 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection.  
F1929-98 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. 
F1980-07 Standard Guide for Accelerated Aging of Sterile Medical Device Packages. 
F2054-07 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates. 
F2095-07e1 Standard Test Methods for Pressure Decay Leak test for Nonporous Flexible Packages with and without Restraining Plates. 
F2096-04 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test). 
F2097-10 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products. 
F2217-02 (2007) Standard Practice for Coating/Adhesive Weight Determination. 
F2227-02 (2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-Sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method. 
F2228-02 (2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging which Incorporates Porous Barrier Material by CO2 Tracer Gas Method. 
F2475-05  Standard Guide for Biocompatibility Evaluation of Medical Device packaging Materials
F2251-03 (2008) Standard Test Method for Thickness Measurement of Flexible Packaging Material.