STN EN ISO 16061
| Name: | STN EN ISO 16061 |
| Validity: | Valid |
| Number of pages: | 28 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Nástroje používané s neaktívnymi chirurgickými implantátmi. Všeobecné požiadavky (ISO 16061: 2021) |
| English title | Instruments for use in association with non-active surgical implants — General requirements |
| Release Date: | 01. 09. 2021 |
| Date of withdrawal: | |
| ICS: | 11.040.40, 11.040.99 |
| Sorting character/National clasification code | 85 2910 |
| Level of incorporation: | idt EN ISO 16061:2021, idt ISO 16061:2021 |
| Official Journal | 08/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 16061:2015-11 (85 2910) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants. This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves. With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer. This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. |
| Preview: | Náhľad normy (PDF) |