Source: https://infostore.saiglobal.com/en-us/Standards/ISO-11135-1994-214207/
Timestamp: 2018-02-22 03:22:46
Document Index: 626274910

Matched Legal Cases: ['art 7', 'art 5', 'art 9', 'art 8', 'art 1', 'art 2', 'art 9', 'art 7', 'art 1', 'art 1', 'art 1', 'art 7', 'art 1', 'art 8', 'art 1', 'art 10', 'art 4', 'art 2', 'art 2', 'art 10', 'art 1', 'art 11', 'art 7', 'art 1', 'art 1', 'art 3', 'art 4', 'art 1', 'art 1', 'art 2', 'art 4', 'art 8', 'art 1', 'art 8', 'art 9', 'art 1', 'art 1', 'art 1', 'art 11', 'art 3', 'art 1', 'art 3', 'art 1', 'art 5', 'art 10', 'art 4', 'art 3', 'art 1', 'art 11', 'art 2', 'art 1']

ISO 11135:1994 | Medical devices - Validation and rout... | SAI Global
ISO 11135:1994
Medical devices - Validation and routine control of ethylene oxide sterilization
Health care technology Medical equipment Health care technology Sterilization and disinfection
Medical equipment in general Sterilization and disinfection in general
ISO/DIS 11135-1.2
ISO/FDIS 11135-1
AAMI TIR16 Ed. 1 (2000) Identical
NEN EN ISO 11135:2004 Identical
AS ISO 11135-2002 Identical
AAMI ISO 11135:1994 Identical
CSA ISO 11135:1998 (R2003) Identical
GOST R ISO 11135:2000 Identical
GB 18279-2000 Identical
KS P ISO 11135:2008 Identical
ISO 9001:2000 Quality management systems - Requirements
ISO 9002:1994 Quality systems - Model for quality assurance in production, installation and servicing
ISO 10993-7:1995 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the validation of a sterilization process
CSA Z10651-5:2008 (R2013) Lung Ventilators For Medical Use - Particular Requirements For Basic Safety And Essential Performance - Part 5: Gas-powered Emergency Resuscitators
I.S. EN ISO 5840:2006 Cardiovascular Implants - Cardiac Valve Prostheses
JIS T 3224:2005 Sterile syringe filter
BS EN ISO 1135-4:2004 Transfusion equipment for medical use. Transfusion sets for single use
ASTM F2407-06 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
CEN ISO/TR 14969:2005 Medical Devices - Quality Management Systems - Guidance On The Application Of Iso 13485:2003
DIN EN ISO 8536-9 (2005-03) Infusion equipment for medical use Part 9: Fluid lines for use with pressure infusion equipment (ISO 8536-9:2004)
NF EN ISO 14161:2002 Sterilization Of Health Care Products - Biological Indicators - Guidance For The Selection, Use And Interpretation Of Results
I.S. EN ISO 8536-8:2004 Infusion Equipment For Medical Use - Part 8: Infusion Equipment For Use With Pressure Infusion Apparatus
ONORM EN ISO 22803:2006 Dentistry - Membrane Materials For Guided Tissue Regeneration In Oral And Maxillofacial Surgery - Contents Of A Technical File
BS EN ISO 7197:2009 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
NF EN ISO 25539-1:2008 Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses
ASTM F1441-03 Standard Specification for Soft-Tissue Expander Devices
BS 7208-19:2001 Contact Lenses And Contact Lens Care Products - Vocabulary - Part 2: Contact Lens Care Products
I.S. EN ISO 8536-9:2005 Infusion Equipment For Medical Use - Part 9: Fluid Lines For Use With Pressure Infusion Equipment
NBR 14990-7:2004 Packaging Systems And Materials For Sterilization Of Health Products Sterilization - Part 7: Pouch And Tube For Ethylene Oxide Sterilization
I.S. EN ISO 11070:1999 Sterile Single-use Intravascular Catheter Introducers
BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses. Fundamental requirements
ISO 10555-1:1995 Sterile, single-use intravascular catheters Part 1: General requirements
NBR ISO 7199:1998
DIN EN ISO 15798 (2001-12) Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001); English version of DIN EN ISO 15798
BS EN ISO 11140-1:2009 Sterilization of health care products. Chemical indicators. General requirements
DIN EN ISO 11140-1 (2006-04) Sterilization of health care products - Chemical indicators Part 1: General requirements (ISO 11140-1:2005)
NBR ISO 14630:2008 Non-active Surgical Implants - General Requirements
08/30179586 DC BS ISO 7199. Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
BS ISO 11712:2009 Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors
DIN EN ISO 14534 (2002-10) Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
BS EN ISO 22794:2007 Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file
I.S. EN ISO 22803:2005 Dentistry - Membrane Materials For Guided Tissue Regeneration In Oral And Maxillofacial Surgery - Contents Of A Technical File
ISO 21649:2006 Needle-free injectors for medical use - Requirements and test methods
DIN EN ISO 21649 (2006-09) Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
BS EN ISO 14534:2002 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
ISO 18369-1:2006 Ophthalmic optics - Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications
I.S. CEN ISO/TR 14969:2005 Medical Devices - Quality Management Systems - Guidance On The Application Of Iso 13485: 2003
ISO 22803:2004 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
CSA ISO 14937:2001 (R2011) Sterilization of Health Care Products - General Requirements for Characteristics of A Sterilizing Agent and the Development, Validation and Routine Control of A Sterilization Process for Medical Devices
I.S. EN ISO 10993-7:1996 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
ONORM EN ISO 25539-1:2009 Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses
BS EN ISO 10993-7:1996 Biological evaluation of medical devices. Ethylene oxide sterilization residuals
BS EN ISO 14937:2001 Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 8536-8:2004 Infusion equipment for medical use Part 8: Infusion equipment for use with pressure infusion apparatus
I.S. EN ISO 17664:2004 Sterilization Of Medical Devices - Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Medical Devices
DIN EN ISO 17664 (2004-07) Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
08/30179592 DC BS ISO 15675. Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
BS EN ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid chemical sterilants
BS EN ISO 11138-2:2009 Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
I.S. EN ISO 22442-1:2007 Medical Devices Utilizing Animal Tissues and Their Derivatives Part 1: Application of Risk Management
ISO 8536-10:2004 Infusion equipment for medical use Part 10: Accessories for fluid lines for use with pressure infusion equipment
ISO/TR 14969:2004 Medical devices - Quality management systems - Guidance on the application of ISO 13485: 2003
BS EN ISO 8536-11:2004 Infusion equipment for medical use. Infusion filters for use with pressure infusion equipment
BS EN ISO 10555-1:2009 Sterile, single-use intravascular catheters. General requirements
DIN EN ISO 1135-4 (2005-03) Transfusion equipment for medical use Part 4: Transfusion sets for single use (ISO 1135-4:2004)
ISO 16672:2003 Ophthalmic implants - Ocular endotamponades
BS ISO 15674:2009 Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
DIN EN ISO 5840 (2006-03) Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
JIS T 3212:2005 Sterile blood transfusion set
I.S. EN 60601-2-12:2006 Medical Electrical Equipment Part 2-12: Particular Requirements For The Safety Of Lung Ventilators - Critical Care Ventilators
BS ISO 15674:2001 Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
BS EN ISO 22803:2005 Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
DIN EN ISO 16672 (2003-06) Ophthalmic implants - Ocular endotamponades (ISO 16672:2003)
I.S. EN ISO 11138-2:2006 Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes
BS EN ISO 8536-10:2004 Infusion equipment for medical use. Accessories for fluid lines for use with pressure infusion equipment
BS ISO 7199:2009+A1:2012 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
BS EN ISO 10555-1:1997 Sterile, single-use intravascular catheters. General requirements
BS ISO 15675:2001 Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial line blood filters
BS EN ISO 8320-2:2001 Contact lenses and contact lens care products. Vocabulary. Contact lens care products
BS ISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters
ISO 11070:1998 Sterile, single-use intravascular catheter introducers
BS EN ISO 21649:2009 Needle-free injectors for medical use. Requirements and test methods
BS EN ISO 17664:2004 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
BS EN ISO 8536-4:2004 Infusion equipment for medical use. Infusion sets for single use, gravity feed
IEC/TR 62354 Ed. 1.0 General testing procedures for medical electrical equipment
I.S. EN ISO 8536-10:2005 Infusion Equipment For Medical Use - Part 10: Accessories For Fluid Lines For Use With Pressure Infusion Equipment
NF EN ISO 11138-1:2006 Sterilization Of Health Care Products - Biological Indicators - Part 1: General Requirements
I.S. EN ISO 8536-11:2005 Infusion Equipment For Medical Use - Part 11: Infusion Filters For Use With Pressure Infusion Equipment
ONORM EN ISO 22794:2007 Dentistry - Implantable Materials For Bone Filling And Augmentation In Oral And Maxillofacial Surgery - Contents Of A Technical File
05/30138310 DC ISO 15882 ED 2. Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
BS ISO 15675:2009 Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
CSA ISO 10993-7:1998 (R2007) Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
BS EN ISO 7197:2006 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
CSA C22.2.60601.1:2008 (R2013) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
I.S. EN ISO 10555-1:1997 Sterile, Single-use Intravascular Catheters - Part 1: General Requirements
ISO 11737-3:2004 Sterilization of medical devices - Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data
08/30184486 DC BS EN ISO 1135-4. Transfusion equipment for medical use. Part 4. Transfusion sets for single use
BS EN ISO 11140-1:2005 Sterilization of health care products. Chemical indicators. General requirements
I.S. EN ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
AS ISO 15539-2003 (R2014) Cardiovascular implants - Endovascular prostheses
CSA ISO 5840:1998 (R2002) Cardiovascular Implants - Caridac Valve Prostheses
DIN EN ISO 22803 (2006-01) Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
JIS T 3211:2005 Sterile infusion administration set
ISO 5840:2005 Cardiovascular implants - Cardiac valve prostheses
IEC 60601-1 Ed. 3.0 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
DIN EN ISO 18369-1 (2006-11) Ophthalmic optics - Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2006)
I.S. EN ISO 11138-3:2006 Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes
I.S. EN ISO 1135-4:2004 Transfusion Equipment For Medical Use - Part 4: Transfusion Sets For Single Use
ISO 16061:2000 Instrumentation for use in association with non-active surgical implants - General requirements
BS EN ISO 15798:2001 Ophthalmic implants. Ophthalmic viscosurgical devices
I.S. EN 13503-8:2000 Ophthalmic Implants - Intraocular Lenses Part 8: Fundamental Requirements
CSA Z11140.1:2007 (R2012) Sterilization Of Health Care Products - Chemical Indicators - Part 1: General Requirements
ISO 15675:2001 Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial line blood filters
ISO 22794:2007 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
CSA ISO 13485:2003 (R2013) Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
CSA Z14161:2006 Sterilization of Health Care Products - Biological Indicators - Guidance for the Selection, Use and Interpretation of Results
AS ISO 5840-2003 Cardiovascular implants - Cardiac valve prostheses
BS EN ISO 5840:2005 Cardiovascular implants. Cardiac valve prostheses
DIN EN ISO 22794 (2007-10) Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007)
ASTM F2560-06 Standard Specification for Supralaryngeal Airways and Connectors
DIN EN ISO 8536-8 (2005-02) Infusion equipment for medical use Part 8: Infusion equipment for use with ; German version EN ISO 8536-8:2004
ISO 8536-9:2004 Infusion equipment for medical use Part 9: Fluid lines for use with pressure infusion equipment
BS EN ISO 11070:1999 Sterile, single-use intravascular catheter introducers
ANSI Z80.27-2001 (R2011) Ophthalmics - Aqueous Shunts For Glaucoma Application
I.S. EN ISO 25539-1:2008 Cardiovascular Implants - Endovascular Devices Part 1: Endovascular Prostheses
AS ISO 16061-2003 Instrumentation for use in association with non-active surgical implants - General requirements
ISO 25539-1:2003 Cardiovascular implants - Endovascular devices Part 1: Endovascular prostheses
BS EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes
PD ISO/TR 14969:2004 Medical Devices - Quality Management Systems - Guidance On The Application Of Iso 13485:2003
BS EN ISO 16672:2003 Ophthalmic implants. Ocular endotamponades
BS EN ISO 14630:2005 Non-active surgical implants. General requirements
I.S. EN ISO 11140-1:2005 Sterilization Of Health Care Products - Chemical Indicators - Part 1: General Requirements
BS EN ISO 14534:1998 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
NF EN ISO 15798:2001 Ophthalmic Implants - Ophthalmic Viscosurgical Devices
DIN EN ISO 8536-11 (2005-03) Infusion equipment for medical use Part 11: Infusion filters for use with pressure infusion equipment (ISO 8536-11:2004)
BS EN ISO 22442-3:2007 Medical Devices Utilizing Animal Tissues And Their Derivatives - Part 3: Validation Of The Elimination And/Or Inactivation Of Viruses And Transmissible Spongiform Encephalopathy (Tse) Agents
I.S. EN ISO 16672:2003 Ophthalmic Implants - Ocular Endotamponades
BS EN ISO 22442-1:2007 Medical Devices Utilizing Animal Tissues And Their Derivatives - Part 1: Application Of Risk Management
BS EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance
CSA ISO 7199:2000 Cardiovascular Implants And Artificial Organs - Blood-gas Exchangers (oxygenators)
CSA ISO TR 14969:2005 (R2015) Medical Devices - Quality Management Systems - Guidance on the Application of Iso 13485:2003
DIN EN ISO 22442-3 (2008-03) Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
I.S. EN ISO 7197:2006 Neurosurgical Implants - Sterile, Single-use Hydrocephalus Shunts And Components
BS EN ISO 8536-8:2004 Infusion equipment for medical use. Infusion equipment for use with pressure infusion apparatus
DIN EN ISO 22442-1 (2008-03) Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management (ISO 22442-1:2007)
ISO 10651-5:2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators
08/30179589 DC BS ISO 15674. Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
BS EN ISO 13485:2003 Medical devices. Quality management systems. Requirements for regulatory purposes
DIN EN ISO 8536-10 (2005-03) Infusion equipment for medical use Part 10: Accessories for fluid lines for use with pressure infusion equipment (ISO 8536-10:2004)
I.S. EN ISO 14937:2000 Sterilisation Of Health Care Products - General Requirements For Characterization Of A Sterilising Agent And The Development, Validation And Routine Control Of A Sterilisation Process For Medical Devices
ISO 15674:2001 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
ONORM EN ISO 5840:2006 Cardiovascular Implants - Cardiac Valve Prostheses
BS EN ISO 25539-1:2009 Cardiovascular implants. Endovascular devices. Endovascular prostheses
BS EN ISO 8536-9:2004 Infusion equipment for medical use. Fluid lines for use with pressure infusion equipment
BS EN ISO 22794:2009 Dentistry - Implantable Materials For Bone Filling And Augmentation In Oral And Maxillofacial Surgery - Contents Of A Technical File
ISO 1135-4:2004 Transfusion equipment for medical use Part 4: Transfusion sets for single use
BS ISO 10651-5:2006 Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Gas-powered emergency resuscitators
I.S. EN ISO 22794:2007 Dentistry - Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File
I.S. EN ISO 14534:2002 Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Fundamental Requirements
BS EN ISO 5840:2009 Cardiovascular Implants - Cardiac Valve Prostheses
NBR ISO 5840:1999
NBR ISO 16061:2002 Instrumentation For Use In Association With Non-active Surgical Implants - General Requirements
BS EN ISO 18369-1:2006+A1:2009 Ophthalmic optics. Contact lenses. Vocabulary, classification system and recommendations for labelling specifications
BS EN ISO 21649:2006 Needle-free injectors for medical use. Requirements and test methods
PD CEN ISO/TR 14969:2005 Medical Devices - Quality Management Systems - Guidance On The Application Of Iso 13485:2003
CSA Z17664:2006 (R2016) Sterilization Of Medical Devices - Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Medical Devices
BS ISO 7197:1997 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
ISO 7197:2006 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components
ISO/TS 15539:2000 Cardiovascular implants - Endovascular prostheses
DIN EN ISO 13485 (2007-10) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (includes Corrigendum AC:2007)
BS EN ISO 11138-2:2006 Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
BS EN 60601-2-12:2006 Medical electrical equipment. Particular requirements for the safety of lung ventilators. Critical care ventilators
ISO 15798:2001 Ophthalmic implants - Ophthalmic viscosurgical devices
ISO 14534:2002 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
I.S. EN ISO 22442-3:2007 Medical Devices Utilizing Animal Tissues and Their Derivatives Part 3: Validation of the Elimination And/or Inactivation of Viruses and Transmissible Spongiform Encephalopathy (tse) Agents
JIS T 3223:2005 Sterile, single-use intravascular catheters over-needle peripheral catheters
I.S. EN 60601-1:2006 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
ISO 8536-11:2004 Infusion equipment for medical use Part 11: Infusion filters for use with pressure infusion equipment
I.S. EN ISO 21649:2006 Needle-free Injectors For Medical Use - Requirements And Test Methods
ISO 11138-2:2006 Sterilization of health care products - Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
I.S. EN ISO 18369-1:2006 Ophthalmic Optics - Contact Lenses Part 1: Vocabulary, Classification System and Recommendations for Labelling Specifications
BS EN ISO 14161:2001 Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
BS EN ISO 14534:2009 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
ISO 13960:2003 Cardiovascular implants and artificial organs - Plasmafilters