ASTM D 6398 : 2008
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Standard Practice to Enhance Identification of Drug Names on Labels
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DI-TCSP-82040 Base Document:2016
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RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
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DD ISO/TS 12417:2011
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Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
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DIN EN ISO 12417-1:2016-02
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
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ANSI/AAMI/ISO 13408-3:2006(R2015)
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
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AAMI TIR15 : 2016
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PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
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ASTM F 2038 : 2000 : EDT 1
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Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
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AAMI ISO 13408-3:2006
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
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ASTM E 3106 : 2017
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Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
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ASTM D 6398 : 2008 : R2014
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Standard Practice to Enhance Identification of Drug Names on Labels (Withdrawn 2022)
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ISO/TS 12417:2011
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Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
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I.S. EN 16679:2014
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PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
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ASTM F 2900 : 2011
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Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
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NFPA 400 : 2016
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HAZARDOUS MATERIALS CODE
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ASME BPE : 2016
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BIOPROCESSING EQUIPMENT
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17/30355946 DC : 0
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BS ISO 21976 - PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
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14/30251609 DC : 0
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BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
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BS EN 16679:2014
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Packaging. Tamper verification features for medicinal product packaging
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AAMI ISO 12417-1 : 2015
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
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ASTM F 2042 : 2000 : R2005
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Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
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ASTM F 2042 : 2000 : EDT 1
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Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
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I.S. EN ISO 12417-1:2015
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
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ASTM F 2383 : 2011 : REDLINE
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Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
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ASTM F 3089 : 2014
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Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
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ANSI/AAMI ST79:2017
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COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
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NFPA 1 : 2021
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FIRE CODE
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ASTM F 2038 : 2000 : R2011
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Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
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BS EN ISO 12417-1:2015
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Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
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ASTM F 2312 : 2011 : REDLINE
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Standard Terminology Relating to Tissue Engineered Medical Products
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UNE-EN ISO 13408-3:2011
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Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
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AAMI TIR48 : 2015
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QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS
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I.S. EN ISO 13408-3:2011
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
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UNI EN ISO 13408-3 : 2011
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
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ASTM F 2212 : 2011 : REDLINE
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Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
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ASTM F 2042 : 2000 : R2011
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
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NFPA 55 : 2016
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COMPRESSED GASES AND CRYOGENIC FLUIDS CODE
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DIN EN ISO 12417-1 E : 2016
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
|
BS EN ISO 13408-3:2011
|
Aseptic processing of health care products Lyophilization
|
ASTM F 2038 : 2000
|
Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
|
PREN 16679 : DRAFT 2013
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PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
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ISO/TR 12417-2:2017
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Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
|
UNE-EN ISO 12417-1:2016
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Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
|
ASTM E 1705 : 2015 : REDLINE
|
Standard Terminology Relating to Biotechnology
|
ASTM F 2038 : 2000 : R2005
|
Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
|
ASTM F 2042 : 2000
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
|
IEC 60601-1-2:2007
|
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
|
ISO 13408-3:2006
|
Aseptic processing of health care products Part 3: Lyophilization
|
ISO 12417-1:2015
|
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
|
EN 16679:2014
|
Packaging - Tamper verification features for medicinal product packaging
|
EN ISO 12417-1:2015
|
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
|
EN ISO 13408-3:2011
|
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
|
AAMI ISO TIR 12417 : 2011
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
|
14/30288557 DC : 0
|
BS EN 16679 - PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
|
ANSI/AAMI/IEC 60601-1-2:2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
|
DIN EN ISO 13408-3:2011-09
|
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
|
ASTM E 2363 : 2014 : REDLINE
|
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
|
ASTM F 2211 : 2013
|
Standard Classification for Tissue Engineered Medical Products (TEMPs)
|
NFPA 1 : 2018
|
FIRE CODE
|