ISO 10310-1995 PDF

Full title and description

ISO 10310:1995 — Neurosurgical implants — Marking and packaging of implantable neural stimulators. Specifies minimum requirements for the marking, labelling, unit-pack and multiple-pack packaging, and accompanying documentation for implantable neural stimulators and associated implanted or external ancillary components (including external control/programming equipment) so that clinicians and patients can identify devices and access essential information easily and safely.

Abstract

Provides requirements for device identification, permanent marking of implant pulse generators and related equipment, unit‑pack and package marking, and the content of accompanying documentation; it does not set clinical indications/contraindications or operational test parameter ranges.

General information

• Status: Withdrawn (withdrawal stage recorded by ISO; standard no longer active).
• Publication date: March 1995 (first edition published 1995-03).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: Edition 1 (1995).
• Number of pages: 6 pages (first edition).

These bibliographic and lifecycle details are recorded on ISO’s catalogue entry for ISO 10310:1995.

Scope

Applies to implantable neural stimulators intended to stimulate the nervous system (brain, spinal cord, peripheral nerves and adjacent structures) and to implanted or external ancillary components used for activation or adjustment of those stimulators. The standard addresses marking, labelling, packaging and the minimum content of accompanying documentation needed for safe identification, handling, storage and clinical decision-making; it does not prescribe clinical indications, contraindications or performance testing parameters.

Key topics and requirements

• Permanent device marking (implant pulse generators, implant RF receivers, programmers/transmitters) — model designation and manufacturer identification.
• Unit-pack and multiple-pack labelling — contents, quantities, serial/lot numbers, manufacturer/supplier name and address.
• Package integrity and legibility — markings that remain readable after normal handling, transit and storage.
• Accompanying documentation — instructions for implantation, adjustment, fault diagnosis, precautions and basic device identification to support clinician and patient use.
• Definitions and rationale (informative annex) explaining the marking/packaging requirements in clinical context.

Typical use and users

Primary users are manufacturers and suppliers of implantable neural stimulators and their packaging/labeling teams, regulatory and quality assurance personnel, and procurement/specifications staff. Clinicians, surgical teams and hospital device management staff rely on the required markings and documentation for device selection, implantation planning and post‑operative management.

Related standards

ISO 10310:1995 sits in the broader family of standards for active implantable medical devices. More recent and wider-scope standards for active implantable devices and specifically implantable neurostimulators include the ISO 14708 series (for active implantable medical devices and particular requirements for implantable neurostimulators), and other ISO/TC 150 deliverables addressing safety, marking and manufacturer information. These newer standards provide expanded and updated requirements beyond the limited scope of ISO 10310:1995.

Keywords

implantable neural stimulator, neurostimulator, marking, labelling, packaging, unit pack, accompanying documentation, active implantable medical device, ISO 10310, ISO 14708.

FAQ

Q: What is this standard?

A: ISO 10310:1995 is an ISO international standard that specified marking, labelling, packaging and documentation requirements for implantable neural stimulators (first edition, published March 1995).

Q: What does it cover?

A: It covers permanent device marking, unit and shipping pack marking, package legibility and the minimum content of accompanying documentation needed for identification, handling and basic clinical use. It does not define clinical indications, contraindications or detailed performance testing parameters.

Q: Who typically uses it?

A: Manufacturers and suppliers of implantable neural stimulators, packaging and labeling specialists, regulatory/QA teams, procurement staff, and clinical teams responsible for device selection and implantation.

Q: Is it current or superseded?

A: ISO 10310:1995 is withdrawn (ISO records withdrawal activity culminating in the withdrawal stage). It is no longer an active standard and has been superseded in practice by broader, later standards covering active implantable medical devices and implantable neurostimulators (see Related standards above).

Q: Is it part of a series?

A: ISO 10310:1995 is a standalone international standard from 1995, but work on comprehensive standards for active implants has continued under ISO/TC 150 (see the ISO 14708 series and related active‑implant standards that now provide general and device‑specific requirements).

Q: What are the key keywords?

A: Implantable neural stimulator, neurostimulator, marking, labelling, packaging, unit pack, accompanying documentation, active implantable medical device, ISO 10310.