Start with the healthcare activity
A hospital management system, a diagnostic examination and a medical-device conformity assessment require different evidence. Establish which organisation, service, product or process you are assessing before selecting a standard.
- Healthcare organisations: quality-management standards can help structure service delivery, risk management and improvement. They do not replace national service, professional or facility requirements.
- Medical laboratories: ISO 15189 addresses quality and competence, including point-of-care testing. Verify the legal entity, location and examinations covered by any accreditation; do not treat it as a guarantee of every result.
- Medical-device and IVD manufacturers: identify the product's intended purpose, regulatory scope and conformity assessment route. The MDR and IVDR address different product scopes. Equipment used in healthcare is not automatically a medical device.
For device-specific selection, risk management and clinical or performance evidence, use our medical-device standards guide.
Match the standard to the work
The references below serve different purposes. They are not a compulsory package or a list of editions currently harmonised under EU law. Verify the current document, amendments, European adoption and scope before use.
| Reference | Relevant work | Boundary to check |
|---|---|---|
| ISO 7101 | Quality management in healthcare organisations. | The organisation and services covered; this is not a medical-device CE-marking route. |
| ISO 15189 / EN ISO 15189 | Medical laboratory quality and competence, including point-of-care testing. | The accredited examination scope, site and current status, plus applicable national requirements. |
| ISO 13485 / EN ISO 13485 | Quality management systems for medical-device organisations. | A QMS certificate alone does not establish product conformity or authorise CE marking. |
| ISO 14971 / EN ISO 14971 | Medical-device risk-management processes across the lifecycle. | Device-specific hazards, controls and evidence; the standard does not prescribe universally acceptable risk levels. |
| ISO 15223-1 / EN ISO 15223-1 | Symbols expressing information supplied for medical devices. | Applicable symbols and editions, user understanding and national language requirements. |
| IEC 60601-1 and related EN standards | Basic safety and essential performance of medical electrical equipment. | Equipment scope and applicable collateral or particular standards; Part 1 alone may not be sufficient. |
| ISO 14155 / EN ISO 14155 | Good clinical practice for medical-device clinical investigations involving human subjects. | The applicable edition and investigation requirements; conformity to the standard does not guarantee acceptance of the resulting evidence. |
| ISO 11135 / EN ISO 11135 | Development, validation and routine control of ethylene oxide sterilisation processes. | The specific product and process; this is not a standard for every sterilisation technology. |
Separate standards, certificates and regulatory duties
Harmonised standards under MDR and IVDR are voluntary. When their references are published in the Official Journal, their use can give a presumption of conformity only for the regulatory requirements they cover. Check the exact edition, amendments and any limitations in the Commission's separate MDR and IVDR lists. An EN or ISO designation by itself does not establish harmonised status.
Distinguish the manufacturer's legal QMS obligations from choosing ISO 13485 and obtaining external certification. A certificate assesses a defined scope; it does not replace the applicable conformity assessment, technical documentation, clinical or performance evidence, or post-market duties. Nor does a standards certificate provide automatic market authorisation in other countries.
Symbols do not remove language requirements
Recognised symbols can communicate particular information on a device or its packaging. They do not create a general exemption from translation. For an MDR device, check Article 10(11) and Annex I section 23 alongside the destination country's rules. Confirm the intended user, required information and document type, including labels and instructions for use.
The Commission's language-requirements overview links separate MDR and IVDR country tables. Requirements can differ for professional and lay users and for different documents. Use those tables as a starting point, then verify current national provisions, which take precedence. Select appropriate symbols under the applicable standard and provide explanations where required; do not assume that a symbol replaces all accompanying safety information.
Prepare a clear brief for specialist support
Record the organisation or product, activity, target country, intended users, existing evidence and deliverable needed. Distinguish an implementation consultant, test laboratory, certification body and, where required, a designated notified body. Ask each provider to confirm the relevant scope before appointment.
- For organisational QMS implementation or audit support, use the ISO specialist enquiry route and state the standard and scope.
- For product or process testing, use the laboratory enquiry route and identify the method, sample and reporting needs. Patient diagnostic examinations require the appropriate clinical service.
- For device classification, MDR/IVDR or technical-documentation work, use the medical-device consultant route.
Before relying on a laboratory's accreditation, check its official record and scope. Our scope-checking guide explains the questions to ask. An introduction does not guarantee provider acceptance, certification or a regulatory outcome.
Find health standards in the catalogue
Compare scope, edition, amendments, language and licence terms before purchase. The external catalogue supports document discovery; a listing does not establish that a document is required, harmonised or sufficient for your project.
Explore Standards for Other Industries
Navigate to other key sectors to find relevant European and International standards.