AAMI ISO 8638 : 2010
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
ISO 13960 : 2010
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - PLASMAFILTERS |
06/30160058 DC : 0
|
BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
15/30275224 DC : 0
|
BS ISO 18242 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS |
DIN EN ISO 3826-4 E : 2015
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
08/30184486 DC : DRAFT JUNE 2008
|
BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE |
DIN EN ISO 8637 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01) |
08/30192448 DC : DRAFT DEC 2008
|
BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
ASTM E 2524 : 2008
|
TEST METHOD FOR ANALYSIS OF HEMOLYTIC PROPERTIES OF NANOPARTICLES |
DIN EN ISO 7199 E : 2017
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
AAMI RD17 : 2007
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
13/30283691 DC : 0
|
BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED |
NBR ISO 10282 : 2014
|
SINGLE-USE STERILE RUBBER SURGICAL GLOVES - SPECIFICATION |
ISO 8637-1 : 2017
|
EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
AAMI ISO 10993-1 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
ASTM F 2065 : 2000 : R2006
|
Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials |
BS EN ISO 1135-3 : 2017
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
ASTM F 1984 : 1999 : R2008
|
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
10/30233840 DC : 0
|
BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
16/30331656 DC : 0
|
BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS |
NBR ISO 10993-1 : 2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
DIN EN ISO 8637 E : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01) |
08/30181526 DC : DRAFT MAY 2008
|
BS EN ISO 15747 - PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS |
CSA Z8638 : 2008
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
16/30331650 DC : 0
|
BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
I.S. EN ISO 1135-5:2015
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
BS ISO 27427 : 2013
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
ISO 5910 : 2018
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
NBR 16163 : 2013
|
PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS |
13/30284773 DC : 0
|
BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
AAMI ISO 15675 : 2016
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
DIN EN ISO 1135-5 : 2016
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
BS ISO 18562-4 : 2017
|
BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
DIN EN ISO 1135-3 : 2014
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
02/564514 DC : DRAFT OCT 2002
|
BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
DIN EN ISO 1135-3 E : 2017
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
AAMI ISO 8637 : 2010
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
ISO TS 20993 : 2006
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON A RISK-MANAGEMENT PROCESS |
BS PD ISO/TR 37137 : 2014
|
CARDIOVASCULAR BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE FOR ABSORBABLE IMPLANTS |
AAMI ISO 7199 : 2009
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
BS EN ISO 3826-4 : 2015
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES |
02/564513 DC : DRAFT OCT 2002
|
BS EN ISO 1135-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE |
01/563307 DC : DRAFT AUG 2001
|
BS ISO 15747 - PLASTICS CONTAINERS FOR INTRAVENOUS INJECTION |
13/30284770 DC : 0
|
BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
CSA ISO 8638 :2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
13/30284776 DC : 0
|
BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
02/564516 DC : DRAFT OCT 2002
|
BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
14/30303657 DC : 0
|
BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE |
17/30344601 DC : 0
|
BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
DIN EN ISO 3826-4 : 2015
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
DIN EN ISO 8638 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
AAMI ISO 10993-1 : 2009 : R2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
CSA Z8637 : 2008
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
CSA ISO 5840 : 0
|
CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES |
CSA ISO 8637: 2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
AAMI ISO 10993-1 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
AAMI ISO TIR 37137 : 2015
|
CARDIOVASCULAR BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE FOR ABSORBABLE IMPLANTS |
ISO 18242 : 2016
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS |
BS EN ISO 7199 : 2017
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
DIN EN ISO 1135-5 E : 2016
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
13/30284721 DC : 0
|
BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION EQUIPMENT FOR USE WITH PRESSURE INFUSION APPARATUS |
CSA ISO 8638 : 2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
BS ISO 18241 : 2016
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS |
NBR 15723-4 : 2010
|
IMPLANTS FOR SURGERY - POLYMERIC MATERIALS - PART 4: SPECIFICATION FOR POROUS POLYETHYLENE POLYMERS |
BS EN ISO 8638 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
DIN EN ISO 8638 E : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
06/30106186 DC : 0
|
ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
13/30283694 DC : 0
|
BS EN ISO 1135-5 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS |
16/30331653 DC : 0
|
BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
02/565260 DC : DRAFT DEC 2002
|
ISO 8638 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
02/564517 DC : DRAFT OCT 2002
|
BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
CSA ISO 8637:2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
02/565247 DC : DRAFT DEC 2002
|
ISO 8637 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
I.S. EN ISO 3826-4:2015
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
ASTM F 2567 : 2006
|
Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials |
02/564518 DC : DRAFT OCT 2002
|
BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR USE WITH PRESSURE INFUSION EQUIPMENT |
03/101659 DC : DRAFT JAN 2003
|
ISO 22803 - DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
BS EN ISO 8637 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01) |
NBR ISO 11193-2 : 2013
|
SINGLE-USE MEDICAL EXAMINATION GLOVES - PART 2: SPECIFICATION FOR GLOVES MADE FROM POLY (VINYL CHLORIDE) |
CSA ISO 8637 : 2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
CSA ISO 8638:2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
AAMI ISO 22442-1 : 2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
CSA ISO 8638 : 2012:R2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
CSA ISO 8638 : 2012 : R2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
CSA ISO 8637 : 2012 : R2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
ASTM F 2065 : 2000 : EDT 1
|
Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials |
ISO 18241 : 2016
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS |
ASTM E 2524 : 2008 : R2013
|
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles |
ASTM F 2567 : 2006 : R2010
|
Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016) |
DIN EN ISO 7199 : 2015
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
UNI EN ISO 8638 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
ASTM F 2567 : 2006
|
PRACTICE FOR TESTING FOR CLASSICAL PATHWAY COMPLEMENT ACTIVATION IN SERUM BY SOLID MATERIALS |
AAMI ISO 18242 : 2016
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS |
I.S. EN ISO 25539-1:2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
I.S. EN ISO 1135-3:2017
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
AAMI ISO 10993-6 : 2016
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
AAMI ISO 18241 : 2016
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS |
I.S. EN ISO 8637:2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01) |
AAMI ISO 8638 : 2010
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
AAMI ISO 8638 : 2010 : R2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
AAMI TIR30 : 2011
|
A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES |
UNE EN ISO 1135-5 : 2016
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
AAMI TIR30 : 2011
|
A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES |
UNE EN ISO 22442-1 : 2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
ASTM F 2848 : 2017 : REDLINE
|
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
NBR ISO 5840 : 1999
|
IMPLANTES CARDIOVASCULARES - PROTESES DE VALVULAS CARDIACAS |
ISO 18562-4 : 2017
|
BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
PREN ISO 3826-1 : DRAFT 2010
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
AAMI RD16 : 2007
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
I.S. EN ISO 8638:2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
UNE EN ISO 1135-3 : 2017
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
I.S. EN ISO 7199:2017
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
ISO/TR 37137 : 2014
|
CARDIOVASCULAR BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE FOR ABSORBABLE IMPLANTS |
ASTM F 1984 : 1999
|
PRACTICE FOR TESTING FOR WHOLE COMPLEMENT ACTIVATION IN SERUM BY SOLID MATERIALS |
ASTM F 2065 : 2000 : R2010
|
Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016) |
UNI EN ISO 22794 : 2009
|
DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
ASTM F 1984 : 1999 : R2013
|
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
ASTM F 2695 : 2012 : REDLINE
|
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
ASTM F 1984 : 1999 : R2003
|
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
UNI EN ISO 8637 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
ASTM F 2065 : 2000
|
PRACTICE FOR TESTING FOR ALTERNATIVE PATHWAY COMPLEMENT ACTIVATION IN SERUM BY SOLID MATERIALS |
ISO 15675 : 2016
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
BS EN ISO 1135-5 : 2015
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS |
AAMI ISO 10993-1 : 2009 : INC : ERR 1 : 2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
AAMI TIR30 : 2011 : R2016
|
A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES |
ASTM E 2524 : 2008
|
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles |
ASTM F 1984 : 1999
|
PRACTICE FOR TESTING FOR WHOLE COMPLEMENT ACTIVATION IN SERUM BY SOLID MATERIALS |
ISO 27427 : 2013
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
DIN EN ISO 3826-1 : 2013
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
UNI EN ISO 3826-1 : 2013
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
VDI 3823-4 : 2006
|
VACUUM COATING QUALITY ASSURANCE - TESTING OF VACUUM COATED PLASTICS |
I.S. EN ISO 3826-1:2013
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
EN ISO 8536-4 : 2013 AMD 1 2013
|
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013) |
ONORM EN ISO 3826-1 : 2013
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
I.S. EN ISO 8536-4:2013
|
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010) |
BS EN ISO 8536-4 : 2013
|
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
DIN EN ISO 22794 : 2009
|
DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
DIN EN ISO 1135-4 : 2016
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
DIN EN ISO 22803 : 2006
|
DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
DIN EN ISO 22442-1 : 2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
DIN EN ISO 22794 E : 2009
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DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
DIN EN ISO 8536-11 E : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
DIN EN ISO 8536-10 E : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
DIN EN ISO 22803 E : 2006
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DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
DIN EN ISO 3826-1 E : 2013
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PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
DIN EN ISO 10993-6 : 2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
DIN EN ISO 8536-8 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
DIN EN ISO 8536-11 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
DIN EN ISO 1135-4 E : 2016
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TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
DIN EN ISO 8536-4 E : 2013
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013) |
DIN EN ISO 8536-4 : 2013
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013) |
DIN EN ISO 8536-8 E : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
DIN EN ISO 8536-10 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
DIN EN ISO 8536-9 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
DIN EN ISO 8536-9 E : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
DIN EN ISO 10993-1 : 2010-04
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
EN ISO 10993-1 : 2009 COR 2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
BS EN ISO 8536-9 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
BS EN ISO 10993-1 : 2009-10
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
DIN EN ISO 22442-1 E : 2016
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MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
ISO 8637 : 2010
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
UNE EN ISO 8536-11 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
UNE EN ISO 8536-9 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
BS EN ISO 8536-11 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
UNE EN ISO 1135-4 : 2016
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TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
BS EN ISO 8536-10 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
ISO 1135-5 : 2015
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TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS |
UNI EN ISO 8536-4 : 2013
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
BS EN ISO 1135-4 : 2015
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TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED |
UNE-EN ISO 8536-4:2013
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013) |
BS EN ISO 10993-6 : 2016
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
BS EN ISO 22442-1 : 2015
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MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
ISO 7199 : 2016
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CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
BS EN ISO 8536-8 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS |
BS EN ISO 22803 : 2005
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DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
ISO 8638 : 2010
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
UNE EN ISO 10993-6 : 2017
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
ISO 10993-6 : 2016
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
ISO 22803 : 2004(R2014)
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DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
EN ISO 7199 : 2017
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CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
ISO 3826-4 : 2015
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PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES |
DIN EN ISO 10993-1 E : 2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
ISO 8536-10 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
ISO 1135-3 : 2016
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TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE |
ISO 3826-1 : 2013
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PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
BS EN 12011 : 1998
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INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
BS EN ISO 3826-1 : 2013
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PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
ISO 22442-1 : 2015
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
ISO 1135-4 : 2015
|
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED |
UNE EN ISO 8536-10 : 2015
|
INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
UNE-EN ISO 3826-1:2013
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
I.S. EN ISO 10993-1:2009+AC:2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
ISO 8536-8 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS |
ISO 10993-1 : 2009-10
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
ISO 8536-9 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
ISO 8536-4 : 2010
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
ISO 8536-11 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
DIN EN ISO 10993-6 E : 2017
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
BS EN ISO 22794 : 2009
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DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
ISO 22794 : 2007(R2017)
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DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
UNE EN ISO 8536-8 : 2015
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
I.S. EN ISO 22442-1:2015
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
EN ISO 22442-1 : 2015
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |