SIST EN 45502-1:2000
(Main)Active implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer
General Information
- Abstract
This Part 1 of EN 45502 specifies requiremnets that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The test that are specified in EN 45502 are type tests and are to be carries out on samples of a device to show compliance. This Part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources ( for example by gas pressure or by springs.). This Part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices (see note 1). NOTE 1: The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICES may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non- implantable parts and accessories if they could affect safety or performance of the implantable device. NOTE 2: The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3: In this European Standard, terms printed in SMALL CAPITAL LETTERS are used as defined in clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
- Status
- Published
- Publication Date
- 31-Mar-2000
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 01-Apr-2000
- Due Date
- 01-Apr-2000
- Completion Date
- 01-Apr-2000
- Directive
- 90/385/EEC - Active implantable medical devicesOJ Ref: C 268 OJ Date: 27-Aug-1998
- Mandate
- BC/CLC/02-89 - BC/CLC/02-89
Overview
SIST EN 45502-1:2000 is the European standard specifying the general safety requirements, marking, and manufacturer information for active implantable medical devices (AIMDs). Developed by the Slovenski inštitut za standardizacijo (SIST), this document is essential for ensuring that AIMDs, including electrically powered or those utilizing other energy sources, meet consistent quality and safety benchmarks across Europe.
This standard aligns with the terminology and regulatory frameworks such as Directive 90/385/EEC, contributing to harmonization within the medical device sector. It applies to both implantable and certain non-implantable components and accessories that could impact the overall performance and safety of the device system.
Key Topics
- General Safety Requirements
- Establishes baseline safety conditions for AIMDs.
- Applies to devices powered by electricity, gas pressure, springs, or similar mechanisms.
- Marking and Labeling
- Outlines mandatory information that must be present on devices and packaging.
- Ensures clear, durable, and traceable marking for patient safety.
- Manufacturer Information
- Specifies the essential information the manufacturer must provide to users and healthcare professionals.
- Includes requirements for handling, maintenance, and safe operation.
- Type Testing
- Defines type tests performed on representative device samples to demonstrate compliance.
- Supports consistency across production batches.
- Scope of Application
- Extends to some non-implantable parts and accessories that may affect device safety or performance.
- Recognizes AIMDs as single devices, combined systems, or assemblies with accessories.
Applications
Implementation of SIST EN 45502-1:2000 is critical for:
- Medical Device Manufacturers
- Ensuring new AIMDs are designed and produced according to uniform European safety standards.
- Providing transparent product information and documentation as required by regulatory authorities.
- Healthcare Providers
- Facilitating the selection and safe use of compliant AIMDs for patient care.
- Supporting proper device identification and traceability in clinical settings.
- Regulatory and Quality Assurance Teams
- Demonstrating product conformity for CE marking and market access.
- Establishing internal quality management protocols and audit readiness.
- Patients and End Users
- Enhancing trust in device safety and reliability through standardized requirements.
- Promoting clear use instructions and safety information.
Related Standards
For specific types of active implantable medical devices, additional requirements are provided in related standards that supplement or modify SIST EN 45502-1:2000:
- EN 45502-2 Series: Covers specific requirements for device categories such as cardiac pacemakers or cochlear implants.
- EN ISO 14971: Focuses on risk management for medical devices.
- Directive 90/385/EEC: Defines regulatory requirements for AIMDs within the European market.
- EN ISO 13485: Specifies quality management systems for medical device manufacturers.
By implementing the guidelines of SIST EN 45502-1:2000 in conjunction with related standards, manufacturers and stakeholders can achieve higher levels of compliance, patient safety, and market acceptance for active implantable medical devices.
Keywords: active implantable medical devices, AIMD, medical device safety, device marking, patient safety, manufacturer requirements, SIST, EN 45502-1, medical device standards, European conformity.
Relations
- Effective Date
- 01-Oct-2010
- Effective Date
- 10-Feb-2026
- Effective Date
- 10-Feb-2026
- Effective Date
- 10-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
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Frequently Asked Questions
SIST EN 45502-1:2000 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Active implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer". This standard covers: This Part 1 of EN 45502 specifies requiremnets that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The test that are specified in EN 45502 are type tests and are to be carries out on samples of a device to show compliance. This Part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources ( for example by gas pressure or by springs.). This Part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices (see note 1). NOTE 1: The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICES may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non- implantable parts and accessories if they could affect safety or performance of the implantable device. NOTE 2: The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3: In this European Standard, terms printed in SMALL CAPITAL LETTERS are used as defined in clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
This Part 1 of EN 45502 specifies requiremnets that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The test that are specified in EN 45502 are type tests and are to be carries out on samples of a device to show compliance. This Part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources ( for example by gas pressure or by springs.). This Part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices (see note 1). NOTE 1: The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICES may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non- implantable parts and accessories if they could affect safety or performance of the implantable device. NOTE 2: The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3: In this European Standard, terms printed in SMALL CAPITAL LETTERS are used as defined in clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
SIST EN 45502-1:2000 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 45502-1:2000 has the following relationships with other standards: It is inter standard links to SIST EN 45502-1:2015, SIST EN 980:2000, SIST EN 540:2000, SIST EN 868-1:2000, SIST EN 60601-2-27:1995, SIST EN 60601-1-1:1995, SIST EN 60601-1:1995, SIST EN 60601-1-2:1995, SIST EN 60601-1-4:1998, SIST EN 60068-2-32:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 45502-1:2000 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC; Standardization Mandates: BC/CLC/02-89, M/432. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 45502-1:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aktive implantierbare medizinische Geräte -- Teil 1: Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu stellende InformationenDispositifs médicaux implantables actifs -- Partie 1: Règles générales de sécurité, marquage et informations fournies par le fabricantActive implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 45502-1:1997SIST EN 45502-1:2000en01-april-2000SIST EN 45502-1:2000SLOVENSKI
STANDARD
SIST EN 45502-
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