{"id":5275,"date":"2025-02-21T01:55:39","date_gmt":"2025-02-21T01:55:39","guid":{"rendered":"https:\/\/kelingmed.com\/?p=5275"},"modified":"2025-02-21T02:00:45","modified_gmt":"2025-02-21T02:00:45","slug":"conformitatea-materialelor-bateriei-pentru-scaune-cu-rotile-drc","status":"publish","type":"post","link":"https:\/\/kelingmed.com\/ro\/conformitatea-materialelor-bateriei-pentru-scaune-cu-rotile-drc\/","title":{"rendered":"Navigarea prin restric\u021biile privind echipamentele medicale din RDC: Transportul bateriilor \u0219i conformitatea materialelor pentru exportatorii de scaune cu rotile"},"content":{"rendered":"<h2><strong>1. Conformitatea transportului de baterii: Protocoale aer vs. mare<\/strong><\/h2>\n<p><strong>A. Certificarea bateriilor cu litiu (actualiz\u0103ri 2025)<\/strong><\/p>\n<ul data-mark=\"-\">\n<li>\n<p>Toate bateriile litiu-ion de peste 100Wh trebuie s\u0103 fie \u00eenso\u021bite de un raport de \u00eencercare UN38.3.<\/p>\n<\/li>\n<li>\n<p><strong>Limitele st\u0103rii de \u00eenc\u0103rcare (SoC)<\/strong>: <\/p>\n<\/li>\n<li>\n<p>Transport aerian: \u226430% taxa pentru baterii vrac <\/p>\n<\/li>\n<li>\n<p>Limit\u0103rile transportului maritim impun ca bateriile litiu-ion s\u0103 r\u0103m\u00e2n\u0103 la un nivel de \u00eenc\u0103rcare sub 50% atunci c\u00e2nd sunt con\u021binute \u00een carcase impermeabile IP67.<\/p>\n<\/li>\n<li>\n<p><strong>Documenta\u021bie<\/strong>: <\/p>\n<\/li>\n<li>\n<p>Documentul MSDS \u00een limba francez\u0103 trebuie s\u0103 prezinte codurile de eliminare specifice Congo \u00een sec\u021biunea 9.3.<\/p>\n<\/li>\n<li>\n<p>Declara\u021bia expeditorului pentru m\u0103rfuri periculoase (SDDG) trebuie s\u0103 fie \u00eenso\u021bit\u0103 de o copie NOTOC\u526f\u672c.<\/p>\n<\/li>\n<\/ul>\n<p><strong>B. Cerin\u021be de ambalare<\/strong><\/p>\n<figure>\n<table>\n<thead>\n<tr>\n<th>Modul de transport<\/th>\n<th>Amortizare<\/th>\n<th>Marcaje<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Aer (IATA)<\/td>\n<td>1.5cm spum\u0103<\/td>\n<td>Etichet\u0103 clasa 9 + identificator \"CAO\".<\/td>\n<\/tr>\n<tr>\n<td>Mare (IMDG)<\/td>\n<td>Pl\u0103ci din fibre ondulate<\/td>\n<td>Baterie litiu Mark (12cm x 11cm)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n<p><strong>Sfat de economisire a costurilor:<\/strong> Pachetele de baterii care \u00eendeplinesc deja certific\u0103rile IEC62133 aduc o reducere de 40% a costurilor de testare.<\/p>\n<hr \/>\n<h2><strong>2. Conformitatea materialelor: Aplicarea REACH &amp; ROHS<\/strong><\/h2>\n<p><strong>A. Praguri pentru substan\u021bele restric\u021bionate<\/strong><\/p>\n<figure>\n<table>\n<thead>\n<tr>\n<th>Substan\u021b\u0103<\/th>\n<th>Limita ROHS<\/th>\n<th>REACH Limita SVHC<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Plumb (Pb)<\/td>\n<td>0.1%<\/td>\n<td>0,01% (anexa XVII la ECHA)<\/td>\n<\/tr>\n<tr>\n<td>DEHP<\/td>\n<td>N\/A<\/td>\n<td>0.1% (Lista candida\u021bilor)<\/td>\n<\/tr>\n<tr>\n<td>Cadmiu<\/td>\n<td>0.01%<\/td>\n<td>0.0025%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n<p><strong>B. Strategia de testare a componentelor<\/strong><\/p>\n<ol start=\"\">\n<li>\n<p><strong>Pre-produc\u021bie<\/strong>: Screening-ul XRF pentru metale reduce timpul de testare cu 22 de zile \u00een compara\u021bie cu metodele complete de laborator.<\/p>\n<\/li>\n<li>\n<p><strong>Controlul loturilor<\/strong>: Piesele din PVC necesit\u0103 testarea aleatorie 5% pentru m\u0103surarea nivelului de ftala\u021bi<\/p>\n<\/li>\n<li>\n<p><strong>Documenta\u021bie<\/strong>: <\/p>\n<\/li>\n<\/ol>\n<ul data-mark=\"-\">\n<li>\n<p>DoC (Declara\u021bia de conformitate) cu marca G <\/p>\n<\/li>\n<li>\n<p>Fi\u0219ier tehnic (aliniere EN 12184:2024) <\/p>\n<\/li>\n<\/ul>\n<p><strong>Termen critic<\/strong>Scaunele rulante care sosesc \u00een portul Matadi dup\u0103 iulie 2025 necesit\u0103 notific\u0103ri complete \u00een baza de date SCIP.<\/p>\n<hr \/>\n<h2><strong>3. Flux de lucru pentru conformitatea \u00een dou\u0103 limbi<\/strong><\/h2>\n<p><strong>Pasul 1: Etichetarea<\/strong><\/p>\n<ul data-mark=\"-\">\n<li>\n<p><strong>Text primar<\/strong>: Francez\u0103 (simboluri ISO 7000 obligatorii) <\/p>\n<\/li>\n<li>\n<p><strong>Text secundar<\/strong>: Englez\u0103 (dimensiunea minim\u0103 a fontului 6pt) <\/p>\n<\/li>\n<li>\n<p>Avertismentele de siguran\u021b\u0103 sunt indicate cu o margine ro\u0219ie folosind Pantone 032C \u0219i includ traduceri \u00een Lingala.<\/p>\n<\/li>\n<\/ul>\n<p><strong>Etapa 2: Documenta\u021bia tehnic\u0103<\/strong><\/p>\n<ul data-mark=\"-\">\n<li>\n<p>Manuale de utilizare: PDF + ghid rapid format A2 <\/p>\n<\/li>\n<li>\n<p>Condi\u021biile de garan\u021bie utilizeaz\u0103 pre\u021burile \u00een moneda CDF \u00een conformitate cu clauzele aprobate de ARMP.<\/p>\n<\/li>\n<\/ul>\n<p><strong>Etapa 3: Supravegherea postcomercializare<\/strong><\/p>\n<ul data-mark=\"-\">\n<li>\n<p>24 de luni de raportare a defectelor c\u0103tre ARSER <\/p>\n<\/li>\n<li>\n<p>Actualizarea anual\u0103 a inventarului substan\u021belor <\/p>\n<\/li>\n<\/ul>\n<hr \/>\n<h2><strong>Concluzie<\/strong><\/h2>\n<p>Distribuitorii de echipamente medicale care respect\u0103 reglement\u0103rile privind bateriile \u0219i materialele din RDC ob\u021bin v\u0103muirea 92% mai rapid dec\u00e2t standardul din industrie. Distribuitorii de echipamente medicale care utilizeaz\u0103 componente precertificate \u00eempreun\u0103 cu documenta\u021bie bilingv\u0103 standardizat\u0103 \u0219i protocoale stricte de testare a loturilor vor atinge conformitatea complet\u0103 cu reglement\u0103rile f\u0103r\u0103 a-\u0219i pierde avantajul competitiv \u00een ceea ce prive\u0219te pre\u021burile.<\/p>\n<h2><strong>\u00ceNTREB\u0102RI FRECVENTE<\/strong><\/h2>\n<p><strong>Q1: Bateriile plumb-acid sunt \u00eenc\u0103 permise \u00een RDC?<\/strong> R: Numai pentru sistemele de rezerv\u0103 de urgen\u021b\u0103 cu certificate de scutire de la Ministerul Mediului. <\/p>\n<p><strong>\u00ce2: Cum se trateaz\u0103 componentele scaunelor cu rotile din materiale mixte?<\/strong> R: Fiecare material (metal\/plastic\/cauciuc) necesit\u0103 un dosar REACH separat - se recomand\u0103 proiectarea modular\u0103. <\/p>\n<p><strong>Q3: Care este sanc\u021biunea pentru etichetarea francez\u0103 neconform\u0103?<\/strong> A: 15% din valoarea transportului sau re\u021binere obligatorie de 60 de zile \u00een depozit. <\/p>\n<hr \/>\n<p><strong>Ob\u021bine\u021bi ast\u0103zi solu\u021bii pentru scaune cu rotile conforme cu DRC<\/strong> \ud83d\udce9 <strong>E-mail<\/strong>: <a href=\"mailto:inquiry@shkeling.com\">inquiry@shkeling.com<\/a> \ud83d\udcf2 <strong>WhatsApp<\/strong>: <a href=\"https:\/\/wa.me\/8618221822482\" target=\"_blank\" rel=\"noopener\">+86 182 2182 2482<\/a> \ud83d\udd0d <strong>Produse certificate<\/strong>: <a href=\"https:\/\/kelingmed.com\/product-category\/wheelchair\/\">Scaune cu rotile Keling Medical<\/a><\/p>\n<p><em>\u00centreba\u021bi despre pachetele noastre de baterii pre-certificate \u0219i kiturile de componente conforme REACH!<\/em><\/p>\n<p>\t\t\t\t\t\t\t\t<svg viewbox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256C504 119 393 8 256 8S8 119 8 256c0 123.78 90.69 226.38 209.25 245V327.69h-63V256h63v-54.64c0-62.15 37-96.48 93.67-96.48 27.14 0 55.52 4.84 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62% dintre refuzurile de expediere a scaunelor cu rotile \u00een RDC rezult\u0103 din \u00eenc\u0103lc\u0103ri ale manipul\u0103rii bateriilor \u0219i din materiale neconforme. Acest ghid ofer\u0103 informa\u021bii utile cu privire la: <\/p>","protected":false},"author":1,"featured_media":5277,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[43],"tags":[],"class_list":["post-5275","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-wheelchair"],"amp_enabled":false,"_links":{"self":[{"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/posts\/5275","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/comments?post=5275"}],"version-history":[{"count":4,"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/posts\/5275\/revisions"}],"predecessor-version":[{"id":5280,"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/posts\/5275\/revisions\/5280"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/media\/5277"}],"wp:attachment":[{"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/media?parent=5275"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/categories?post=5275"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kelingmed.com\/ro\/wp-json\/wp\/v2\/tags?post=5275"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}