CROSS-STANDARD public interest · PPE / respirator (mask)
China-to-Chile PPE Respirator (FFP Mask) Compliance Gap Matrix
AI-compiled from official public sources — cross-checked by multiple AI models, not human-verified. Informational only; see disclaimer. Public-interest, source-linked comparison of Chinese PPE respirator (KN95 / GB 2626) documentation against Chile's occupational respiratory protective equipment requirements: Instituto de Salud Publica (ISP) certification for occupational PPE, the DS 594 workplace hygiene and safety framework, INN/NCh standards adopting EN 149, and importer obligations. Note: respirators are occupational PPE regulated by ISP, not electrical products under SEC.
Dataset 2026-06-11
Last verified 2026-06-15
6 rows
GAP MATRIX
Compliance Gap Matrix
| Compliance item | Common China baseline | Chile (SEC) | Gap / action | Source + verification date |
|---|---|---|---|---|
| Conformity Assessment — ISP Certification of Occupational Respirators (No EU-style Notified Body / CE Regime) | For industrial respiratory protection under GB 2626-2019 (KN95/KN90), China applies a compulsory certification (CCC) scheme administered by SAMR/CNCA and third-party certification bodies (e.g., China Quality Certification Centre, CQC). Conformity assessment involves type testing by a CNAS-accredited laboratory followed by factory inspection. For medical-protective masks (GB 19083-2010), NMPA registration as a medical device is required. Neither the Chinese CCC scheme nor the NMPA medical device registration is automatically recognised by ISP — the Chinese certification does not substitute for ISP certification of the model under the Chilean occupational PPE regime.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (CCC mandatory certification under SAMR/CNCA) GB 19083-2010 — Technical requirements for medical protective mask (NMPA medical device registration) |
In Chile, personal protective equipment used to protect workers — including filtering respirators — must be certified before it can be supplied for occupational use. The competent authority is the Instituto de Salud Publica de Chile (ISP), which under the Codigo Sanitario and the workplace hygiene framework Decreto Supremo No 594 (Ministerio de Salud) operates the certification and quality-control regime for occupational PPE. The certification verifies that the respirator model meets a recognised performance standard (Chile's INN adopts international standards as Norma Chilena, NCh, and EN 149 / NIOSH 42 CFR 84 / equivalents are commonly accepted reference standards). Unlike the EU, Chile does NOT operate a horizontal CE marking system with private Notified Bodies and modular conformity assessment (Module B / C2 / D). Instead the route is: (1) test the model to an accepted standard (often at an accredited laboratory); (2) obtain ISP certification/authorisation for that specific PPE model; (3) the certified model is then lawful to supply for occupational use, with the employer obligated under DS 594 to provide certified PPE. SEC (Superintendencia de Electricidad y Combustibles) is NOT involved — SEC governs electrical and fuel-burning products, not respiratory PPE.Decreto Supremo No 594 (Ministerio de Salud) — Reglamento sobre condiciones sanitarias y ambientales basicas en los lugares de trabajo (workplace PPE obligation) Instituto de Salud Publica de Chile (ISP) — certification / quality control of occupational personal protective equipment Norma Chilena (NCh) standards issued by INN adopting EN 149 / international respirator performance standards |
The conformity route must be re-run for Chile. Specific gaps: (1) ISP certification of the respirator model is required — Chinese CCC certificates and NMPA registrations do not substitute for it; (2) the model must be tested to a standard ISP accepts (EN 149 / NCh adoption of EN 149 / NIOSH 42 CFR 84 / equivalents) — a GB 2626 KN95 report alone is generally not sufficient; (3) Chile has no CE mark and no Notified-Body modular system, so exporters should not assume CE documentation transfers — the Chilean route is ISP product certification; (4) an in-country importer of record is needed to place product on the market and to interface with ISP and customs (DIN import declaration via Aduanas); (5) the employer's DS 594 duty to supply only certified PPE means uncertified respirators cannot lawfully be used in Chilean workplaces.[INFORMATIONAL] Occupational respirators require certification by the Instituto de Salud Publica de Chile (ISP), not SEC, and Chile has no EU-style CE marking or Notified-Body modular conformity regime. Chinese CCC or NMPA certifications do not satisfy this requirement. Exporters must have the specific model tested to an ISP-accepted standard (commonly EN 149 / its NCh adoption) and obtain ISP certification, working through an in-country importer, before respirators may be supplied for workplace use under DS 594. | Instituto de Salud Publica de Chile (ISP)2026-06-15 · reference |
| Product Labelling and Instructions — Spanish Language + EN 149/NCh Marking for the Chilean Market | GB 2626-2019 Clause 7 specifies Chinese marking for non-powered air-purifying particle respirators. Required on the product: manufacturer name or trademark, product name, model, standard number (GB 2626-2019), performance class (KN90 or KN95), and the NR or R designation. Required on the packaging: manufacturer name, address and contact, production date and shelf life (or expiry), batch number, storage conditions, and instructions for use in Chinese. The CCC mark must appear on product and packaging. Key differences from Chile: Chinese markings are in Chinese (Chile requires Spanish); the CCC mark is used (Chile uses no CCC mark and the ISP certificate is the conformity evidence); the standard cited is GB 2626 (Chile references EN 149 / NCh or NIOSH).GB 2626-2019 — Clause 7 (marking and packaging requirements) China CCC (3C) mark — mandatory product certification mark on product and packaging |
Occupational respirators supplied in Chile must carry marking consistent with the accepted product standard and must provide user information in SPANISH. Where EN 149 (as adopted in NCh) is the reference standard, the device marking typically includes: the standard reference (EN 149:2001+A1:2009 or the equivalent NCh number), manufacturer name/trademark, model/type designation, performance class (FFP1/FFP2/FFP3), and the NR (not re-usable) or R (re-usable) designation, with D added if the dolomite clogging test was passed. (If NIOSH 42 CFR 84 is the certified standard, the N95/N99/N100 designation and NIOSH approval marking apply instead.) The packaging and instructions for use must be in Spanish for the Chilean market and should cover donning/doffing, fit-check, limitations of use, storage conditions, shelf life / batch information, and the manufacturer and Chilean importer identification. The ISP certification status of the model should be traceable. Chile does NOT require a CE mark and does NOT use a Notified-Body number on the product; a SEC seal is NOT applicable to respirators.EN 149:2001+A1:2009 — Clause 9 (marking) as adopted in Norma Chilena and referenced by ISP NIOSH 42 CFR 84 — alternative marking (N95/N99/N100, NIOSH approval) where that standard is certified Decreto Supremo No 594 (Ministerio de Salud) and ISP requirements — Spanish-language user information for occupational PPE |
Labelling gaps typical for Chinese exporters to Chile: (1) LANGUAGE: Chinese-only instructions are not acceptable — instructions for use and key packaging information must be provided in Spanish. (2) STANDARD CITATION: the product/marking should reference EN 149 (or its NCh adoption) or NIOSH 42 CFR 84 — the standard under which ISP certified the model — rather than GB 2626. (3) CLASS DESIGNATION: use the certified class (FFP1/FFP2/FFP3 or N95/N99/N100); do NOT label the product 'KN95' while marketing it as FFP2, since the classes use different test methods and that is misleading. (4) NO CCC / NO CE: the CCC mark should not be relied on for the Chilean market and there is no CE mark; the operative evidence is the ISP certificate, traceable via the importer. (5) IMPORTER DETAILS: Chilean importer identification should appear on packaging/documentation. (6) SHELF LIFE / BATCH: batch number and shelf-life/expiry information should be clearly shown for traceability and labour-inspection purposes. (7) NO SEC SEAL: do not apply or reference a SEC seal — it is for electrical/fuel products, not respirators.[INFORMATIONAL] FFP respirators for the Chilean market require Spanish-language instructions and marking consistent with the standard under which ISP certified the model (EN 149 / its NCh adoption, or NIOSH 42 CFR 84). Chinese-only labelling, the CCC mark, and GB 2626 standard references are not sufficient, and labelling a product 'KN95' while marketing it as FFP2 is misleading. There is no CE mark, no Notified-Body number, and no SEC seal for respirators in Chile; the ISP certificate, traceable through the Chilean importer, is the operative conformity evidence. | Instituto de Salud Publica de Chile (ISP) — Salud Ocupacional2026-06-15 · reference |
| ISP Certification Evidence, Importer of Record, and Conformity Documentation (No CE Mark / No EU Authorised Representative) | China does not require CE or ISP marks. Domestic conformity is shown via the CCC mark (mandatory for GB 2626 industrial respirators), affixed after certification by a CNCA-authorised body, or NMPA registration (for GB 19083 medical masks). There is no Chinese requirement equivalent to a Chilean importer of record / RUT-holding importer for domestic placement, and no requirement equivalent to a foreign Authorised Representative. CCC marks and NMPA registration documents are not accepted by Chilean authorities (ISP / Aduanas) as evidence of Chilean conformity.China CCC (3C) certification — CNCA mandatory certification system for GB 2626-2019 industrial respirators NMPA medical device registration — for GB 19083 medical-protective masks |
Before occupational respirators are supplied in Chile, the responsible party must hold and be able to produce: (1) ISP CERTIFICATION of the specific respirator model as occupational PPE, evidencing testing to an accepted standard (EN 149 / NCh adoption or NIOSH 42 CFR 84); (2) the underlying TEST REPORT(S) from an accredited or recognised laboratory; (3) an IMPORTER OF RECORD established in Chile (with Chilean RUT) who lodges the customs import declaration (DIN) through Aduanas and is the entity placing the product on the Chilean market and accountable to ISP and labour-inspection authorities. Chile does NOT use a CE mark, has NO four-digit Notified-Body number, and has NO EU-style 'Authorised Representative' construct; the functional equivalent is the ISP certificate held by/through the Chilean importer/distributor. SEC certification and SEC seals are NOT applicable to respirators (those apply to electrical and fuel products). Where the buyer is a Chilean employer, that employer relies on the ISP certificate to discharge its DS 594 duty to provide certified PPE. Spanish-language product and supplier documentation is expected for the Chilean market.Instituto de Salud Publica de Chile (ISP) — PPE certificate as the conformity document for occupational respirators Servicio Nacional de Aduanas — import declaration (Declaracion de Ingreso, DIN) lodged by the Chilean importer of record Decreto Supremo No 594 (Ministerio de Salud) — employer duty supported by the ISP certificate |
Gaps to close for Chile: (1) ISP CERTIFICATE: obtain ISP certification of the specific model as occupational PPE; CCC/NMPA documents do not substitute. (2) IMPORTER OF RECORD: appoint or contract a Chilean importer/distributor with a RUT to lodge the DIN through Aduanas and place the product on the market — there is no remote 'Authorised Representative' shortcut as in the EU. (3) NO CE / NO NB NUMBER: do not attempt to rely on a CE mark or a Notified-Body number; they have no legal effect in Chile and ISP certification is the operative document. (4) SEC IS IRRELEVANT: respirators are occupational PPE, not electrical products — do not seek SEC approval for them. (5) SPANISH DOCUMENTATION: supplier declarations, instructions, and the conformity dossier should be available in Spanish for the Chilean buyer/employer and authorities. (6) Retain test reports and the ISP certificate for traceability and labour-inspection audit.[INFORMATIONAL] For Chile the operative conformity document is the ISP certificate of the respirator model, held by/through a Chilean importer of record who lodges the customs import declaration. Chile has no CE mark, no Notified-Body number, no EU-style Authorised Representative, and SEC approval does not apply to respirators. Chinese CCC marks and NMPA registrations do not substitute for ISP certification, and Spanish-language supplier documentation should accompany the product. | Instituto de Salud Publica de Chile (ISP)2026-06-15 · reference |
| Filtering Respirator Safety Performance — EN 149 / NCh Reference Standard (ISP-certified) | China's primary standard for non-powered air-purifying particle respirators is GB 2626-2019, with classes KN90 and KN95 (oily-aerosol classes KP also exist). GB 2626-2019 is a mandatory national standard enforced by SAMR. KN95 requires >=95% filtration efficiency against NaCl particles at 85 L/min. Key differences from EN 149: GB 2626 KN-series uses sodium chloride (NaCl) aerosol (EN 149 uses both NaCl and paraffin oil for the same class); GB 2626 does not require the simulated-workplace total-inward-leakage test in the same form; and dolomite clogging is tested differently. A GB 2626 KN95 report is therefore not automatically equivalent to an EN 149 FFP2 result, and is not by itself accepted by ISP for Chilean occupational-PPE certification.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (mandatory national standard, SAMR) GB/T 32610-2016 — Technical specification of daily protective mask (voluntary, general public — not industrial PPE) |
Occupational filtering respirators supplied in Chile must meet a recognised respiratory-protection performance standard and be certified by the Instituto de Salud Publica (ISP). Chile's national standards body, the Instituto Nacional de Normalizacion (INN), adopts international standards as Norma Chilena (NCh); for filtering half masks the EN 149 (FFP1/FFP2/FFP3) performance classes are commonly referenced, and ISP also accepts NIOSH 42 CFR 84 (N95/N99/N100) and equivalent recognised standards. EN 149:2001+A1:2009 specifies three classes: FFP1 (>=80% filtration), FFP2 (>=94% filtration, total inward leakage <=8%), FFP3 (>=99% filtration, total inward leakage <=2%). Requirements cover filtration efficiency against solid and liquid aerosols (NaCl and paraffin oil), inhalation and exhalation breathing resistance, CO2 content of inhaled air, total inward leakage on human subjects, dolomite clogging resistance, and flammability. The certified model must carry evidence of testing to the accepted standard for ISP to authorise it for occupational use under DS 594. Mining and heavy industry are major respirator-using sectors in Chile and the SUSESO/mutualidades occupational-safety system reinforces the certified-PPE requirement.EN 149:2001+A1:2009 — Respiratory protective devices — Filtering half masks to protect against particles (adopted as Norma Chilena / accepted by ISP) NIOSH 42 CFR 84 — alternative recognised respirator standard (N95/N99/N100) accepted by ISP Decreto Supremo No 594 (Ministerio de Salud) — employer duty to provide ISP-certified respiratory PPE |
Exporters must have the respirator model tested to an ISP-accepted standard and obtain ISP certification. A GB 2626-2019 (KN95) report does not satisfy this because: (1) EN 149 requires paraffin oil aerosol testing in addition to NaCl for the FFP classes; (2) EN 149 requires a simulated-workplace total-inward-leakage test on human subjects; (3) dolomite clogging and flammability test protocols differ; (4) filtration thresholds differ numerically (KN95 = 95% NaCl only; FFP2 = 94% both aerosols plus total inward leakage limit). ISP requires testing to the accepted standard (EN 149 / NCh adoption, or NIOSH 42 CFR 84) — partial bridging from GB 2626 alone is not accepted. Where an accredited Chilean or recognised foreign laboratory report to EN 149 / NIOSH already exists, it can support the ISP certification dossier.[INFORMATIONAL] Occupational filtering respirators for Chile must be tested to an ISP-accepted performance standard (commonly EN 149 as adopted in NCh, or NIOSH 42 CFR 84) and certified by the ISP before supply under DS 594. Chinese GB 2626-2019 (KN95) certification does not by itself satisfy Chilean requirements — full testing to the accepted standard (including the paraffin oil aerosol and simulated-workplace tests absent from GB 2626) plus ISP certification is required. | Instituto de Salud Publica de Chile (ISP) — Salud Ocupacional2026-06-15 · reference |
| Medical-Protective Respirator Safety — GB 19083 (China) vs Chile Health-Product Route (No Horizontal RoHS/Battery/Outdoor-Noise Regime) | GB 19083-2010 (Technical requirements for medical protective mask) requires >=95% filtration efficiency (NaCl aerosol), surface moisture resistance, synthetic blood penetration resistance, and pressure differential testing, and is enforced by NMPA as a medical device. Products certified under GB 19083 in China are regulated as medical devices domestically, not as industrial PPE under GB 2626. For Chile, such a product follows the ISP health-product / medical-device route (Codigo Sanitario) if it carries clinical claims; if it is supplied purely as occupational respiratory PPE, it follows the ISP PPE route (DS 594) and must be tested to EN 149 / NIOSH equivalents. There is no Chilean RoHS, battery, or outdoor-noise regime to additionally satisfy for a non-powered mask.GB 19083-2010 — Technical requirements for medical protective mask (NMPA, medical device classification) | This row addresses the Chinese medical-protective respirator standard (GB 19083) and how it maps to Chile. In Chile, a respirator that serves a clinical / infection-control function (protecting patient or environment, or used in healthcare settings) is regulated as a health product / medical device under the Codigo Sanitario, controlled by the ISP medical-device function — a different pathway from the DS 594 occupational-PPE route covered in row 001. A purely occupational FFP-type respirator follows the ISP PPE route. PLAIN-LANGUAGE NOTE ON ABSENT HORIZONTAL REGIMES: Chile does NOT operate EU-style horizontal product regulations for these masks — there is no Chilean equivalent of the EU RoHS Directive (hazardous substances in electronics), no EU-style battery regulation, and no EU-style outdoor-noise directive that would apply to a non-powered filtering respirator. These EU horizontal regimes are simply not part of the Chilean respirator route. Material-safety and biocompatibility expectations instead flow from the accepted product standard (EN 149 / NIOSH for PPE; the relevant medical-device requirements for the health-product route) and from ISP certification, not from a separate horizontal substances/battery/noise law.GB 19083-2010 — Technical requirements for medical protective mask (China, mandatory, SAMR/NMPA) Codigo Sanitario (Chile) — health products / medical devices controlled by ISP (route for clinical/medical respirators) Decreto Supremo No 594 (Ministerio de Salud) — occupational-PPE route for non-medical filtering respirators |
GB 19083 certification is for China's domestic medical device market and has no direct Chilean equivalent recognition. (1) If the respirator is supplied for occupational use, it must be tested to an ISP-accepted PPE standard (EN 149 / NIOSH) and ISP-certified under the DS 594 route — GB 19083 does not transfer. (2) If it carries clinical/medical claims, it must instead follow the ISP health-product / medical-device control path under the Codigo Sanitario, which has its own registration/authorisation and importer requirements. (3) Exporters should NOT expect to satisfy EU-style horizontal regimes (RoHS, battery, outdoor-noise) because Chile does not apply them to filtering respirators — but they MUST satisfy the correct ISP route for the declared purpose. Mixing occupational and medical claims without holding both authorisations is a common cause of sanitary-authority or customs rejection.[INFORMATIONAL] GB 19083 (Chinese medical-protective mask) certification is not recognised in Chile. Exporters must choose the correct Chilean route based on declared purpose: ISP occupational-PPE certification (EN 149 / NIOSH, under DS 594) for worker-protecting respirators, or ISP health-product / medical-device authorisation (Codigo Sanitario) for clinical/medical masks. Chile applies no EU-style RoHS, battery, or outdoor-noise horizontal regimes to filtering respirators — the controlling requirement is the correct ISP pathway, not those horizontal laws. | Instituto de Salud Publica de Chile (ISP) — Dispositivos Medicos2026-06-15 · reference |
| CRITICAL BOUNDARY: Occupational PPE Respirator vs. Medical Device — Which Chilean Authority Applies? | China uses a three-track classification system for respiratory masks: (1) INDUSTRIAL / NON-MEDICAL: GB 2626-2019 (KN90/KN95) — particle respirators for occupational use, mandatory CCC, administered by SAMR; (2) MEDICAL-PROTECTIVE: GB 19083-2010 (>=95% filtration, medical-grade) — for highly infectious environments, administered by NMPA as a medical device; (3) SURGICAL MASK: YY 0469-2011 (Medical surgical mask) — for surgical use, NMPA medical device. The Chinese three-track system partially maps to Chile's purpose-based split: GB 2626 industrial respirators map to the ISP occupational-PPE route (DS 594), while GB 19083 / YY 0469 medical products map to the ISP health-product / medical-device route under the Codigo Sanitario. KN95 (GB 2626) is not the same as FFP2 (EN 149) because the test methods differ, even though Chile commonly references EN 149.GB 2626-2019 — Non-powered air-purifying particle respirator (KN90/KN95) — SAMR/CCC GB 19083-2010 — Technical requirements for medical protective mask — NMPA YY 0469-2011 — Medical surgical mask — Technical requirements — NMPA |
The classification decision determines which Chilean regime applies, and is one of the most commercially significant choices for respiratory products entering Chile. The determining factor is the INTENDED PURPOSE declared by the manufacturer. (A) OCCUPATIONAL FILTERING RESPIRATORS (PPE ROUTE): Products intended to protect the WEARER against airborne particles, aerosols, dusts, or hazardous workplace atmospheres. Route: occupational PPE under Decreto Supremo No 594 (Ministerio de Salud) with certification by the Instituto de Salud Publica (ISP); reference performance standard EN 149 (adopted as NCh) or NIOSH 42 CFR 84 equivalents. This is the route addressed in this comparison. (B) MEDICAL / SURGICAL MASKS (HEALTH-PRODUCT ROUTE): Products intended to protect the PATIENT or ENVIRONMENT from the wearer's emissions, or used in clinical/surgical settings, are regulated as health products / medical devices under the Codigo Sanitario, controlled by the ISP's medical-device control and registration functions (the same institute, but a different regulatory pathway). (C) Chile does NOT operate the EU's twin-regulation split (PPE Reg 2016/425 vs MDR 2017/745) — instead the ISP is the single competent institute spanning both occupational PPE certification and health-product control, but the documentation, standard, and authorisation path differ by intended use. Important: SEC plays NO role for either route — SEC governs electrical/fuel products, not masks.Decreto Supremo No 594 (Ministerio de Salud) — occupational PPE framework (wearer-protecting respirators: ISP PPE certification route) Codigo Sanitario (Chile) — health products / medical devices control by ISP (patient/environment-protecting surgical masks route) EN 149 (adopted as Norma Chilena) — filtering half masks to protect against particles (occupational PPE reference standard) |
The single most important classification decision is what the product label and instructions claim. (1) If the product claims WEARER PROTECTION against particles/dusts/aerosols (worker safety, industrial, mining): the occupational-PPE route applies, requiring ISP PPE certification of the model and compliance with DS 594. (2) If the product claims PATIENT/ENVIRONMENT PROTECTION or clinical/surgical use: the health-product / medical-device route under the Codigo Sanitario applies, with ISP medical-device control. COMMON EXPORT MISTAKE: Chinese manufacturers label KN95 (GB 2626) masks with surgical or medical language to target multiple buyers. In Chile, surgical/medical claims move the product into the health-product route (different documentation and authorisation), while occupational use requires ISP PPE certification — a mismatch between the claim and the certification held can trigger customs or sanitary-authority rejection. Note that Chile, unlike the EU, does not have a dual CE+MDR conformity scheme, but the purpose-based ISP split still determines which authorisation is needed.[INFORMATIONAL — CRITICAL BOUNDARY] In Chile the intended purpose determines the route: wearer-protecting occupational respirators follow the ISP occupational-PPE certification path under DS 594 (EN 149 / NCh reference), while surgical/medical masks follow the ISP health-product / medical-device path under the Codigo Sanitario. Chile has no EU-style dual CE+MDR scheme and SEC is not involved. Chinese KN95 (GB 2626) respirators exported for occupational use must follow the ISP PPE route; adding surgical or medical claims reroutes the product to the health-product authorisation, and a mismatch can cause sanitary or customs rejection. | Instituto de Salud Publica de Chile (ISP)2026-06-15 · reference |
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SOURCES
Official-source register.
- Instituto de Salud Publica de Chile (ISP) · accessed 2026-06-15 · reference · used in 3 rows
- Instituto de Salud Publica de Chile (ISP) — Salud Ocupacional · accessed 2026-06-15 · reference · used in 2 rows
- Instituto de Salud Publica de Chile (ISP) — Dispositivos Medicos · accessed 2026-06-15 · reference · used in 1 rows