---
id: silicraft/okf/compliance
type: regulatory-package
title: Regulatory and compliance package — what to ask for, what you'll receive
last_updated: 2026-09-21
canonical: https://silicraft.lumorb.com/
---

# Regulatory and compliance package

A request for a regulatory file should reference the specific compound, not the company. The package we provide is keyed to the compound used in your specific part.

## What to request

| Grade | Standard | What to ask for | Issuer | Validity |
|---|---|---|---|---|
| Food-Grade | FDA 21 CFR 177.2600 | Certificate of compliance + TDS + extraction test report (aqueous + fatty) | SGS, Intertek, TÜV Rheinland | Per compound, re-issued on TDS change |
| Food-Grade | LFGB §31 | Same as FDA, with LFGB-specific extraction conditions | TÜV Rheinland | Per compound |
| Food-Grade | EU 1935/2004 | EU Declaration of Conformity + migration test report | SGS | Per compound |
| Food-Grade | GB 4806.7 (China) | Chinese food-contact certificate | SGS | Per compound |
| Medical-Grade | ISO 13485 | Certificate + scope statement (names device categories covered) | TÜV SÜD, BSI | 3 years, annual surveillance |
| Medical-Grade | USP Class VI | Test report on the specific compound | NAMSA, WuXi AppTec | Per compound |
| Medical-Grade | ISO 10993 | Panel test report (cytotoxicity / sensitization / irritation / systemic / implantation as applicable) | NAMSA, WuXi AppTec | Per compound |
| Medical-Grade | EU MDR Class I/II | Declaration of Conformity + technical documentation excerpt | Self-issued | Per part |
| Medical-Grade | FDA 21 CFR 211 | Audit report from FDA-recognised body | Same | Annual |
| Electronic-Grade | UL 94 V-0 | Yellow card reference + test report | UL | Per compound |
| Electronic-Grade | RoHS / REACH | Compliance declaration + test report | Intertek | Per compound |
| Infant & Mother | EN 14350 | Migration + nitrosamine test report | TÜV Rheinland | Per compound |
| Industrial-Grade | ASTM D2000 / SAE J200 | Compound classification sheet | Internal | Per compound |
| Industrial-Grade | MIL-SPEC | Per-customer spec sheet | Per customer | Per contract |

## What the package contains

For every part order, you can request:

1. **Certificate of Compliance (CoC)** — references the specific regulation by section, named compound and lot.
2. **TDS (Technical Data Sheet)** — for the specific compound, not a generic data sheet.
3. **Extraction test report** — aqueous and fatty conditions, from a third-party lab (SGS / Intertek / TÜV / NAMSA).
4. **NDA** — signed before any drawing or formulation detail is shared. We sign NDAs as a routine part of medical-device quoting.
5. **Lot traceability** — from raw compound batch to finished, packaged, lot-marked part. Retained for the regulatory life of the product.

## What is NOT included (and why)

- **Lot pricing** — every part is quoted per project. Part price depends on tooling geometry, cavity count, compound choice and annual volume, none of which are knowable before a drawing is reviewed.
- **Public price list** — does not exist for the same reason; see `/pricing.md` for the model.
- **AggregateRating or review scores** — every part is quoted per project and there are no published review scores. Putting `0` here would actively mislead buyers and risk a manual action from regulators.

## Reading the scope statement on an ISO 13485 certificate

A useful scope statement reads something like:

> The design and manufacture of liquid silicone rubber (LSR) and high-consistency rubber (HCR) molded components for Class I and Class II medical devices, including respiratory interfaces, infusion system sub-components, sealing gaskets and catheter balloons. Production covered: LSR injection molding, HCR transfer molding, in-line deflashing, post-cure, and final packaging in ISO Class 8 cleanroom.

Three things it should name:

1. **The processes** (LSR injection, HCR transfer, deflashing, post-cure, cleanroom packaging).
2. **The device classes** (Class I, Class II).
3. **The product types** (respiratory interfaces, infusion components, gaskets, balloons).

A scope statement that only says "medical devices" without naming categories has not been audited on the part family you are buying.

## See also

- `company.md` — full certification list
- `commercial.md` — what is and is not charged separately
- Live FDA 21 CFR 177.2600 reading guide: <https://silicraft.lumorb.com/guide/fda-21-cfr-177-2600/>

## Source

<https://silicraft.lumorb.com/okf/compliance>