Evidence and how to check it
Nine documents stand behind the numbers on this site. For each one we state who issued it, what it establishes, and what it does not cover — because the third part is what makes the first two usable.
The evidence ledger
Every row is a document a buyer can request and, where a registry exists, look up independently.
EstablishesThe plant's quality system has been audited by an external body.
Does not establishNot a medical-device QMS, and not ISO 13485.
EstablishesEnvironmental management at the site is externally audited.
Does not establishSays nothing about any product property.
EstablishesOccupational health and safety management is externally audited.
Does not establishSays nothing about any product property.
EstablishesRestricted-substance content is declared against the directive lists.
Does not establishIt is a declaration, not biocompatibility and not finished-device compliance.
EstablishesThe material passes the in-vivo reactivity screen.
Does not establishDoes not cover a finished device, nor long-term implant.
EstablishesCytotoxicity, sensitisation and irritation are characterised at material level.
Does not establishDoes not replace the device-level biological evaluation.
EstablishesIrritation index 0.0 at 52 weeks, no different from the negative control.
Does not establishDoes not cover your geometry, sterilisation or manufacturing process.
EstablishesThe material chapter of a device submission can cite the file.
Does not establishDoes not approve a device, transfer to you, or replace ISO 10993.
EstablishesA government body independently recognised the technical work.
Does not establishIs not product-performance data or registration evidence.
Test methods, and when two numbers can be compared
The same polymer tested to ASTM and to ISO does not give the same number. This table says which comparisons are legitimate before you put two suppliers in one spreadsheet.
| Property | ASTM | ISO | GB/T | Comparability |
|---|---|---|---|---|
| Tensile strength, elongation at break | D412 | 37 | GB/T 528 | Different specimen and rate — values not comparable |
| Tear strength | D624 | 34-1 | GB/T 529 | Different specimen and rate — values not comparable |
| Hardness, Shore A / D | D2240 | 868 | GB/T 531.1 | Read-out time changes the result — quote it with the value |
| Density | D792 | 2781 | GB/T 533 | Equivalent methods — directly comparable |
| Compression set | D395 | 815 | GB/T 7759.1 | Comparable only if temperature, time and compression match |
| Melt flow rate | D1238 | 1133 | GB/T 3682.1 | Comparable only if temperature, time and compression match |
| Vicat softening temperature | D1525 | 306 | GB/T 1633 | Comparable only if temperature, time and compression match |
| Heat ageing in air | D573 | 188 | GB/T 3512 | Comparable only if temperature, time and compression match |
| Flame rating | UL 94 | IEC 60695-11-10 | GB/T 2408 | Thickness decides the rating — the value is meaningless without it |
| Biocompatibility | — | 10993 series | GB/T 16886 | GB/T 16886 adopts ISO 10993 — read the part number, not the family name |
Comparability is judged on specimen geometry and test rate. Standard revisions differ by year; the current edition of each standard governs.
How to verify us without trusting us
None of the above requires our cooperation beyond sending the file. These four steps are what a supplier audit does, and they work on any supplier, ours included.
- Ask for the certificate of analysis of the lot you will receive, and check that its lot number matches the sample the report was run on.
- Look the report or certificate number up on the issuing body's own website. A PDF from a supplier proves nothing that a registry lookup does not confirm.
- Re-test the same lot in your own laboratory, with the method named in the table above, and compare values together with the test conditions.
- Ask for the first page of the report unredacted: laboratory name, accreditation mark, date, and the conditions the test was run under.
Tell us the grade and the intended contact category, and we release the reports that apply to it — not a generic pack.