ISO/FDIS 8637-3, Extracorporeal systems for blood purification — Part 3: Plasmafilters (50.20)
ISO/DTS 7020, Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 (50.00)
ISO/FDIS 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables (50.00)
ISO/FDIS 18969, Clinical evaluation of medical devices - Principles and process for planning and performing clinical evaluation (50.00)
ISO/FDIS 21762, Medical devices utilizing non-viable human materials — Application of risk management (50.00)
ISO/DTS 21726, Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents (50.00)
ISO/DIS 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements (40.99)
ISO/DIS 20014, Implants for surgery — Test method for the evaluation of delamination resistance of ultra-high molecular weight polyethylene materials used for orthopaedic implants (40.99)
ISO/DIS 16428, Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices (40.60)
ISO/DIS 13782, Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications (40.60)
ISO/DIS 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (40.60)
ISO/DIS 7206-6, Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components (40.60)
ISO/DIS 5832-12, Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy (40.60)
ISO/DIS 5832-14, Implants for surgery — Metallic materials — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy (40.60)
ISO/DIS 5832-9, Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel (40.60)
ISO/DIS 6474-1, Implants for surgery — Ceramic materials: Alumina — Part 1: Monolithic high-purity alumina (40.60)
ISO/DIS 7198, Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches (40.60)
IEC/DIS 80601-2-31, Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (40.60)
ISO/DIS 10974, Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device (40.60)
ISO/DIS 10993-11.2, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (40.60)
ISO/DIS 13356, Implants for surgery —Alumina ceramic material: Zirconia — Yttria-stabilized tetragonal zirconia (Y-TZP) (40.20)
ISO/DIS 14708-1, Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (40.20)
ISO/DIS 19213, Implants for surgery — Test methods of material for use as a cortical bone model (40.20)
ISO/DIS 19227, Implants for surgery — Cleanliness of orthopedic implants — General requirements (40.20)
ISO/DIS 7206-1, Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions (40.00)
ISO/CD 25695, Medical devices utilizing bioengineered biological substances — Application of risk management (30.60)
ISO/CD 25735, Device output-parameters, abbreviations, and units for displaying and storage in extracorporeal life support (30.60)
ISO/CD 8250, Characterization of residuals relevant to the biological evaluation of medical devices (30.60)
ISO/CD TR 24850, Sources of hazard information for medical device constituents (30.60)
ISO/CD TS 17137, Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants (30.60)
ISO/CD TS 20324, Generation of medical device extracts for chemical analysis to support toxicological risk assessment (30.60)
ISO/CD TS 25364-2.2, Analytical chemistry matters associated with ISO 10993-18 — Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA) (30.60)
ISO/CD TS 25364-3, Analytical chemistry matters associated with ISO 10993-18 — Part 3: Instrumental and human requirements for evaluating organic medical device extractables and leachables via Non-Targeted Analysis (NTA) (30.60)
ISO/CD TS 26177, Biological evaluation of medical devices – Guidance on risk estimation and evaluation in the application of ISO 10993-1 (30.60)
ISO/CD TS 26420, Biological evaluation of medical devices — Guidance on the impact of bioaccumulation and intermittent contact in the application of ISO 10993-1 (30.60)
ISO/CD 23500-1, Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements (30.60)
ISO/CD 23500-2, Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies (30.60)
ISO/CD 23500-3, Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies (30.60)
ISO/CD 23500-4, Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies (30.60)
ISO/CD 23500-5, Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies (30.60)
ISO/CD 14243-1, Implants for surgery — Wear of total knee-joint prostheses — Part 1: Methodology for simulator wear testing of tibio-femoral joints under force control (30.60)
ISO/CD 14243-3, Implants for surgery — Wear of total knee-joint prostheses — Part 3: Methodology for simulator wear testing of tibio-femoral joints under displacement control. (30.60)
ISO/CD 24085-1, Implants for Surgery — Partial and total shoulder joint replacement — Part 1: Determination of resistance to torque of head fixation of modular humeral components (30.20)
ISO/CD 16436-2, Implants for surgery — Wear of total shoulder-joint prostheses — Part 2: Methodology for simulator wear testing of reverse total shoulder-joint prostheses (30.20)
ISO/CD 18993, Implants for surgery — Joint replacement implants — Methods for cleaning, wear measurements, and wear rate determination (30.00)
IEC/AWI TS 63757, Single fault conditions of magnetic resonance equipment and other considerations for magnetic resonance conditional implant assessments (20.00)
ISO/AWI 7614, Tissue-engineered medical products — The method for quantification of residual DNA in decellularized ECM scaffolds (20.00)
ISO/AWI TS 11967, Biological evaluation of medical devices — Guidance on commissioning scientifically robust chemical characterization testing in accordance with ISO 10993-18 (20.00)
ISO/AWI TS 24830, Application of in-silico/read-across approaches for identifying a medical device constituent analogue (20.00)
ISO/AWI TS 25364-4, Analytical chemistry matters associated with ISO 10993-18 — Part 4: Critical aspects of extract viability in extractables and leachables testing using non-targeted analysis (NTA) (20.00)
ISO/AWI 14155, Clinical investigation of medical devices for human subjects — Good clinical practice (20.00)
ISO/AWI 22442-1, Medical devices utilizing tissues and their derivatives — Part 1: Application of risk management (20.00)
ISO/AWI 22442-2, Medical devices utilizing tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (20.00)
ISO/AWI 26302, Ventricular assist devices and total artificial hearts (20.00)
ISO/AWI 5832-1, Implants for surgery — Metallic materials — Part 1: Wrought stainless steel (20.00)
ISO/AWI 22442-3, 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 (10.99)
ISO 5834-1:2025/AWI Cor 1, Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form — Technical Corrigendum 1 (10.99)
ISO 6631:2025/AWI Amd 1, Tissue-engineered medical products — Quantification of bovine type I collagen marker peptide with liquid chromatography — Tandem mass spectrometry — Amendment 1 (10.99)
ISO/AWI 10993-13, Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (10.99)
ISO/AWI 10993-14, Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (10.99)
ISO/AWI 11318, Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements (10.99)
ISO/AWI 12891-1, Retrieval and analysis of surgical implants — Part 1: Retrieval and handling (10.99)
ISO/AWI 12891-2, Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants (10.99)
ISO/AWI 13781, Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing (10.99)
ISO/AWI 5841-3, Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers (10.99)
ISO/AWI 7206-2, Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials (10.99)
EN ISO 16061:2021/prA11, Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021) (10.99)
EN ISO 21534:2009/prA11, Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007) (10.99)
ISO/NP 25405.3, Tissue-engineered medical products-General requirement of bio-derived scaffold material for peripheral nerve repair (10.60)
ISO/NP 27132, Non-active surgical implants — General requirements for personalized surgical implants (10.20)
ISO/NP TS 27161, Radial expansion resistance characterization of flexible surgical heart valve prostheses (10.20)
ISO/PWI 4403, Implants for surgery — Test method for flexural strength of porous calcium salt bone void filler after preconditioning in deaerated phosphate buffered saline (00.60)
ISO/PWI 25281, Tissue engineered medical products — Characterization and evaluation of recombinant collagen as starting material for TEMPs (00.60)
ISO/PWI 25406, Tissue Engineered Medical Products — Characterization and evaluation of silk fibroin as a starting material for TEMPs (00.60)
ISO/PWI 10993-10, Biological evaluation of medical devices — Part 10: Tests for skin sensitization (00.00)
ISO/PWI 10993-23, Biological evaluation of medical devices — Part 23: Tests for irritation (00.00)
ISO/PWI 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (00.00)
ISO/PWI 13175-3, Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes (00.00)
ISO/PWI 14117.2, Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices (00.00)
ISO/PWI 14242-3.2, Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test (00.00)
ISO/PWI 14242-4.2, Implants for surgery — Wear of total hip-joint prostheses — Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading (00.00)
ISO/PWI 14243-5.2, Implants for surgery — Wear of total knee prostheses — Part 5: Durability performance of the patellofemoral joint (00.00)
ISO/PWI 14708-2, Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers (00.00)
ISO/PWI 14708-3, Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators (00.00)
ISO/PWI 14708-6, Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (00.00)
ISO/PWI 14949.2, Implants for surgery — Two-part addition-cure silicone elastomers (00.00)
ISO/PWI 16054, Implants for surgery — Minimum data sets for surgical implants (00.00)
ISO/PWI 16061, Instruments for use in association with non-active surgical implants — General requirements (00.00)
ISO/PWI 16087.2, Implants for surgery — Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants (00.00)
ISO/PWI 18368, Implants for surgery — Nitride ceramic materials — Monolithic materials made of beta silicon-nitride (00.00)
ISO/PWI 18531, Implants for surgery — Calcium salt based bioceramics — Characterization of hardening bone paste materials (00.00)
ISO/PWI 22622, Implants for surgery — Wear of total ankle-joint prostheses — Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test (00.00)
ISO/PWI 24085-2, Implants for Surgery - Partial and total shoulder joint prosthesis — Part 2: Determination of resistance to torque-off head fixation of modular humeral prostheses (00.00)
ISO/PWI 24964, EMC for leadless pacemakers (00.00)
ISO/PWI 26710, Transcatheter delivery systems for cardiac valves repair and replacement (00.00)
ISO/PWI 27153, Transcatheter delivery systems for cardiac valves repair and replacement (00.00)
ISO/PWI 27169, Implants for surgery - Shelf life and stability evaluation (00.00)
