Medical Pack Solutions
﹛Standards and
Test Methods
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Medical Pack Solutions |
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﹛Standards and Test Methods |
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ISO Standards |
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| 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. | |
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European Standards |
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| 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 | |
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ASTM Test Methods |
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| 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. | |
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