Healthcare
Safety and quality are non-negotiable in the medical devices industry.
Regulatory requirements for medical devices are increasingly stringent throughout every step of a product’s life cycle, including service and delivery.
The International Organization for Standardization (ISO) is an independent organization dedicated to publishing quality and risk management standards for product development in a variety of industries, including medical devices.
FEATURED
Standards Library
Access the latest European Voluntary Standards. All documents are officially verified and regularly updated to reflect current regulations.
18
Standards
5
Categories
PDF
+ DOCX
Type
Name
Language
Format
NEW ISO, Aerospace, Healthcare
ISO 9001 2026 versus ISO 9001 2015
Quality management systems – Requirements
English
$80.00
including VAT
$45.00
including VAT
$120.00
including VAT
NEW Healthcare
WHO QRM 2026 versus WHO QRM 2003
WHO guidelines on quality risk management
English
$75.00
including VAT
$45.00
including VAT
$115.00
including VAT
NEW ISO, Healthcare
ISO 10451:2026 versus ISO 10451:2010
Dentistry — Contents of a technical file for dental implant systems
English
ISO, Healthcare
ISO 5364:2026 versus ISO 5364:2016
Anaesthetic and respiratory equipment — Oropharyngeal airways
English
Healthcare, ISO
ISO 14155:2026 versus ISO 14155:2020
Clinical investigation of medical devices for human subjects — Good clinical practice
English
ISO, Healthcare
ISO 80369-1:2025 Versus ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications
Part-1: General Requirements
English
$55.00
including VAT
$35.00
including VAT
$75.00
including VAT
ISO, Healthcare
ISO 10993-7:2026 versus ISO 10993-7:2018+A1:2022
Biological evaluation of medical devices
Part 7: Ethylene oxide sterilization residuals
English
$95.00
including VAT
$35.00
including VAT
$110.00
including VAT
Healthcare, ISO
ISO 10993-6:2026 vs ISO 10993-6:2016
Biological evaluation of medical devices Part 6: Tests for local effects after implantation
English
$65.00
including VAT
$40.00
including VAT
$95.00
including VAT
Healthcare, ISO
ISO 20417:2026 vs ISO 20417:2021
Medical devices — Information to be supplied by the manufacturer
English
$65.00
including VAT
$35.00
including VAT
$95.00
including VAT
Healthcare, IEC
IEC 62083-2026 Vs IEC 62083-2010
Medical device software — Requirements for the safety of radiotherapy treatment planning systems
English
$75.00
including VAT
$30.00
including VAT
$110.00
including VAT