| ISO 8827 First edition 1988-10-15 Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements |
| Recognition Number | Orthopedic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 11-184 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Clause 8 Packaging Clause 9 Marking of packages |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Orthopedic |
| FDA Tech | Jonathan Peck FDA/OMPT/CDRH/ODE/DOD/PSDB/ 301-796-5650 jonathan.peck@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because: Clauses 8 and 9 refer to ISO 6018:1987 Orthopaedic implants - General requirements for marking, packaging, and labeling, which is withdrawn. See ISO 11607-1 & 2 below.
This International Standard covers general requirements and the designation of dimensions and tolerances of staples with parallel legs intended for use in orthopaedic surgery.
NOTE - The annex gives guidance on the selection and use of staples and does not form an integral part of this International Standard.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3030 | Staple, Fixation, Bone | Class 2 | JDR |
| ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. |