Reusable Surgical-Instrument Fastening
Connect precision joints with cleanability, sterilization-method compatibility, corrosion and traceability requirements.
Medical Device Fastening Applications
Explore fastening applications, engineering requirements, joining technologies and technical references across surgical, diagnostic, laboratory and patient-care equipment.
HF2A Medical Devices does not cover fastening applications inside the human body, including implantable fasteners.
Medical Device Applications
Engineering Requirements
Fasteners & Joining Technologies
Standards & Specifications
Materials & Reprocessing Standards10 references
ISO 7153-1:2016Surgical instruments — Materials — Part 1: Metals
ASTM F899-23Wrought stainless steels for surgical instruments
ISO 13402:2025Surgical and dental hand instruments — Resistance against autoclaving, corrosion and thermal exposure
ISO 17664-1:2021Processing information for critical and semi-critical medical devices
ISO 17664-2:2021Processing information for non-critical medical devices
ISO 17665:2024Moist-heat sterilization processes for medical devices
ISO 11135:2014 + Amd 1:2018Ethylene-oxide sterilization processes; revision in final-draft stage
ISO 11137-1:2025Radiation sterilization processes
ISO 14937:2009General requirements for sterilizing-agent characterization and sterilization-process validation
ISO 15883-1:2024Washer-disinfectors — General requirements and tests
Testing & Performance3 references
ISO 11737-1:2018Bioburden determination; revision under development
ASTM F2503-26MR-environment safety marking for medical devices and other items
ISO 10993-1:2025Biological safety evaluation within risk management, where patient contact makes it applicable
Medical Equipment & System Requirements9 references
IEC 60601-1:2005 + Amd 1:2012 + Amd 2:2020Basic safety and essential performance of medical electrical equipment
IEC 60601-1-2:2014 + Amd 1:2020Electromagnetic disturbances
IEC 80601-2-52:2026Medical beds for adults
ISO 7176 seriesWheelchairs
ISO 10535:2021Hoists for the transfer of persons
IEC 61010-1:2010 + Amd 1:2016Electrical equipment for measurement, control and laboratory use
ISO 7494-1:2018Stationary dental units and dental patient chairs — General requirements
ISO 7494-2:2022Dental units and chairs — Air, water, suction and wastewater systems
ISO 9680:2026Dentistry — Operating lights
Quality & Regulatory Requirements5 references
ISO 13485:2016Medical-device quality management systems
ISO 14971:2019Medical-device risk management
21 CFR Part 820FDA Quality Management System Regulation (QMSR), 21 CFR Part 820 — United States; effective 2026-02-02
EU 2017/745 (MDR)Regulation (EU) 2017/745 (MDR) — European Union medical-device regulatory framework
EU 2017/746 (IVDR)Regulation (EU) 2017/746 (IVDR) — European Union IVD regulatory framework, where applicable
Standards note: This is a selected reference set, not an exhaustive compliance list. Verify the current edition, jurisdictional adoption and project / OEM requirements before use.
Additional note: Applicability depends on device classification, intended use, patient contact, reprocessing method, electrical function and market. HF2A Medical Devices continues to exclude implantable fastening applications.
Industry Members
Medical-device member profiles will appear here as participating companies complete their capability information.
Medical Device Technical Resources
Cleaning, Disinfection & Sterilization Effects on Fastened Joints
Review steam, EO, radiation, detergents and disinfectants as material / surface / joint-selection conditions.
Medical Equipment Grounding, Retention & Serviceability
Review protective grounding, captive hardware, enclosure integrity and repeated service in electrical medical equipment.
MR-Environment Fastening & Magnetic Material Selection
Separate fastener material selection from item-level MR safety classification and review where low-magnetic hardware is actually required.